Retroperitoneal SarcomaNCT05631379
Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma
An observational study of Retroperitoneal Sarcoma and Body Composition, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Sarcoma, Body Composition, Malnutrition
- What is being tested?
- Measurement of body composition with computed tomography (CT), GLIM malnutrition criteria and EWGSOP2 sarcopenia criteria
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 2 Dec 2022to 4 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020
Who may be able to join
- Patients aged above 18 years old
- Patients with primary localized RPS or pelvic sarcoma operated at Surgical Department of Institute of Oncology in Ljubljana
Who cannot join
- Patients with Gastrointestinal Stromal Tumors (GISTs) and Retroperitoneal desmoid-type fibromatosis (DF)
- Patients with visceral sarcomas (arising from visceral organ i.e., gastrointestinal, and genitourinary tracts sarcoma)
- Patients with benign retroperitoneal / pelvic tumors
- Patients with residual RPS operated at another hospital
- Patients with present recurrent, secondary, and metastatic RPS
- Unable to access patients' data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Body Composition, Nutritional Status and Inflammatory Markers on Survival and Postoperative Outcome in Patients Operated on for Primary Retroperitoneal Sarcoma: Report From Institute of Oncology Ljubljana
This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity.
Read the detailed description
Retroperitoneal sarcomas (RPS) are rare neoplasms of mesenchymal origin with estimated crude incidence of 0.3 cases per 100000 inhabitants per year. The most common histologic subtypes are well-differentiated and dedifferentiated liposarcoma and leiomyosarcoma, accounting for 42% and 26% of cases, respectively. RPS are optimally managed in multidisciplinary settings in specialized sarcoma centers. Surgical resection with an adequate margin of normal tissue is the cornerstone of curative therapy and en bloc surgical resection of localized tumors is the recommended surgical approach. This "extended" surgical approach (including resection of adjacent organs), is optimal for reducing local recurrence and improving overall survival.
Cancer patients undergoing surgical treatment face number of challenges which negatively impact their nutritional status. Patients are usually in catabolic state, which together with ongoing proteolysis and lipolysis as well as decreased protein synthesis contribute to development of cancer - associated cachexia. Most important nutritional disorders in these patients are malnutrition, sarcopenia, cancer cachexia. On the other side, often under-recognized, sarcopenic obesity is gaining attention in clinical and research settings.
The association of malnutrition and poor postoperative outcome has been demonstrated in patients with various cancer locations. Malnourished patients reportedly have longer length of postoperative stay (LOS), higher rates of 30-day mortality, infection rate, sepsis, reoperation, increased number of cardiopulmonary complications. Diagnostic process of malnutrition has been a topic of debate considering inconsistency in diagnostic methodology and criteria. Global Leadership Initiative on Malnutrition (GLIM) addressed this problem and recommended a new diagnostic scheme for malnutrition, in form of consensus report incorporating previous finding and recommendations from world leading clinical nutrition societies. To our knowledge, no study validated GLIM criteria in patients with primary RPS.
Sarcopenia is clinical syndrome characterized by generalized skeletal muscle mass loss, loss of strength and function (performance). Sarcopenia has been associated with lower survival rate and proved to be an independent predictor of survival in patients with breast cancer, pancreatic adenocarcinoma, hepatocellular carcinoma, and melanoma. There is a lack of studies investigating the impact of sarcopenia on survival and postoperative outcome in patients with soft-tissue sarcoma (STS), including retroperitoneal sarcoma. Similarly to malnutrition diagnosis, there is an evident inconsistency and confusion in diagnostic criteria and tools used to define and characterize sarcopenia in clinical practice and research. However, recently the European Working Group on Sarcopenia in Older People (EWGSOP2) published updated findings in form of Revised European Consensus. The Working Group proposed new recommendation, among which are those related to establishing specific cut-off points for body composition (primarily skeletal muscle quantity and quality) measures that identify and characterize sarcopenia.
Sarcopenic obesity (SO) is co-existence of sarcopenia and excess adiposity. Recent expert consensus of The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) will be followed for definition and diagnostic criteria for SO.
Myosteatosis is ectopic adipose tissue infiltration in skeletal muscle. Intermuscular adipose tissue can be quantified using CT scans by low muscle radiodensity. CT-derived myosteatosis contributes to impaired glucose metabolism, including insulin resistance, type 2 diabetes mellitus, and inflammation. Additionally, it may increase the risk for dyslipidemia. Myosteatosis may predict oncologic and postoperative outcome in primary RPS patients.
Patients with primary RPS are in a great risk for malnutrition, sarcopenia and cachexia for the number of reasons: requirement for demanding abdominal surgery in their management, catabolic tumor effects, long period before diagnosis of RPS and tumor size (approximately 15 cm). Due to their rarity, it is still unclear how preoperative nutritional status and body composition impact outcome of patients with primary RPS.
STUDY DESIGN DATA COLLECTION Patient's histories including the anaesthetician's preoperative reports, surgeon's operative reports, hospital records, and follow-up data will be collected. Paper and electronic data archive of Institute of Oncology Ljubljana Patient Data Information System will be used.
The following preoperative clinical data will be acquired: age, sex, preoperative weight, height, significant weight loss, appetite loss and weakness. CT reports will be also acquired for analysis as well as histopathological diagnosis (subtype), stage, grade and tumor size.
The preoperative laboratory data, including absolute counts of leukocytes, neutrophils, lymphocytes, monocytes and platelets, CRP, and albumin levels will be assessed. Data will be deidentified and whenever possible all measures to conceal patient identifiers and maintain patient confidentiality will be taken.
STATISTICAL CONSIDERATIONS The data will be presented using appropriate summary statistics: mean, median, standard deviation for continuous variables and percentages and frequencies for categorical variables. Kaplan-Meier method will be used for survival curves analysis and differences between survival rates compared using the log-rank test. The independent prognostic variables for survival (OS and LRFS) will be identified using Cox proportional hazard model (hazard ratio, 95% confidence interval, p value).
ETHICS The study was approved by Slovenian National Medical Ethics Committee, Institute of Oncology Ljubljana Review Board and Institute of Oncology Ljubljana Ethical Committee. The need to obtain informed consent from participants was waived.
- Conditions
- Retroperitoneal Sarcoma, Body Composition, Malnutrition, Sarcopenia, Sarcopenic Obesity, Myosteatosis
- Being tested
- Measurement of body composition with computed tomography (CT), GLIM malnutrition criteria, EWGSOP2 sarcopenia criteria, ESPEN-EASO criteria for sarcopenic obesity, Prognostic Nutritional Index (PNI)
- Medical subject headings
- Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of body composition with computed tomography (CT)Other
The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), muscle radiation attenuation (MRA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)
GLIM malnutrition criteriaDiagnostic test
GLIM criteria (Global Leadership Initiative on Malnutrition) will be applied to assess malnutrition
EWGSOP2 sarcopenia criteriaDiagnostic test
EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia
ESPEN-EASO criteria for sarcopenic obesityDiagnostic test
The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) consensus criteria from 2018 will be applied to assess sarcopenic obesity
Prognostic Nutritional Index (PNI)Diagnostic test
Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count
The high-sensitivity modified Glasgow prognostic scoreDiagnostic test
The high-sensitivity modified Glasgow prognostic score (Hs-mGPS) is an inflammation-based score consisted of C-reactive protein level and serum albumin
| Study group | Role | What they receive |
|---|---|---|
| All patients meeting inclusion criteria | All patients meeting inclusion criteria Receives: Diagnostic Test: GLIM malnutrition criteria; Diagnostic Test: Prognostic Nutritional Index (PNI); Diagnostic Test: The high-sensitivity modified Glasgow prognostic score | |
| Subgroup of patients with available preoperative CT/MRI scans | Subgroup of patients with available preoperative CT/MRI scans will be detected and body composition measurements will be assessed min order to detect nutrition-related syndromes Receives: Other: Measurement of body composition with computed tomography (CT); Diagnostic Test: GLIM malnutrition criteria; Diagnostic Test: EWGSOP2 sarcopenia criteria; Diagnostic Test: ESPEN-EASO criteria for sarcopenic obesity; Diagnostic Test: Prognostic Nutritional Index (PNI); Diagnostic Test: The high-sensitivity modified Glasgow prognostic score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Complications graded by Clavien-Dindo Complication Classification System
Measured: within 30 days after surgery
Local recurrence rate
A postoperative local recurrence will be defined by biopsy-proven or radiographic evidence of local recurrent disease
Measured: From date of surgery until the date of first documented local progression assessed until June 2020
Mortality
Overall survival (OS) will be defined as the time between the date of the operation to the date of death from any cause or last follow-up (according to medical records and using telephone contacts)
Measured: Length of survival after surgery until June 2020 (up to 130 months)
Secondary outcomes (11)
Length of hospital stay
Time interval from the date of operation to the date of discharge. Body composition parameters may predict the length of hospital stay
Measured: up to 90 days after surgery
Major postoperative morbidity
Complication grade 3 or higher according to Clavien-Dindo Complication Classification System
Measured: within 90 days after surgery
Prevalence of preoperative malnutrition in primary RPS patients
A prevalent case of malnutrition will be considered if a patient fulfills the Global Leadership Initiative on Malnutrition (GLIM) criteria. GLIM proposed 5 diagnostic criteria to assess malnutrition and includes 3 phenotypic (weight loss, low body mass index and reduced muscle mass) and 2 etiologic (reduced food intake/assimilation, and inflammation/disease burden) criteria. To diagnose malnutrition at least 1 phenotypic criterion and 1 etiologic criterion should be present
Measured: within 30 days before surgery
Prevalence of preoperative sarcopenia in primary RPS patients
A prevalent case of sarcopenia will be considered if a patient fulfills the diagnostic criteria defined by European Working Group on Sarcopenia in Older People (EWGSOP2)
Measured: within 30 days before surgery
To evaluate the impact of skeletal muscle area (SMA) on the prognosis of patients with primary RPS
Skeletal muscle area (SMA) area will be measured by using preoperative computed tomography (CT) scans at lumbar (L3) vertebral level and recorded as cm^2 using standard Hounsfield Unit thresholds of - 29 to + 150. SMA at the third lumbar spine level has been established as a good indicator of whole-body muscle mass.
Measured: through study completion, an average of 6 months
To evaluate the impact of the muscle radiation attenuation (MRA) on the prognosis of patients with primary RPS
Muscle radiation attenuation (MRA) will be assessed using CT scans at lumbar (L3) vertebral level and recorded as mean Hounsfield unit (HU) of each pixel within a region of interest. MRA reflects muscle composition, including the degree of intramuscular fat accumulation, important to define the presence of myosteatosis
Measured: through study completion, an average of 6 months
To evaluate the impact of visceral adipose tissue (VAT) on the prognosis of patients with primary RPS
Visceral adipose tissue (VAT) area will be measured by using preoperative computed tomography (CT) scans at lumbar (L3) vertebral level and recorded as cm^2 using standard Hounsfield Unit thresholds of -150 to -50
Measured: through study completion, an average of 6 months
To evaluate the impact of subcutaneous adipose tissue (SAT) on the prognosis of patients with primary RPS
Subcutaneous adipose tissue (SAT) area will be measured by using preoperative computed tomography (CT) scans at lumbar (L3) vertebral level and recorded as cm^2 using standard Hounsfield Unit thresholds of -190 to -30.
Measured: through study completion, an average of 6 months
To evaluate the impact of visceral-to-subcutaneous adipose tissue area ratio (VSR) on the prognosis of patients with primary RPS
Visceral-to-subcutaneous adipose tissue ratio will be calculated by dividing the visceral adipose tissue area by the subcutaneous adipose tissue area.
Measured: through study completion, an average of 6 months
To assess the impact of complete blood count based systemic inflammatory markers: NLR, PLR and SII on the prognosis of patients with primary RPS
Neutrophil to lymphocyte ratio (NLR): calculated as the absolute neutrophil count divided by the absolute lymphocyte count.
Platelet to Lymphocyte Ratio (PLR): calculated as the absolute platelet count divided by the absolute lymphocyte count.
Systemic immune inflammation index (SII): based on absolute platelet, neutrophil and lymphocyte count and calculated according to following formula:
SII =(platelet count×neutrophil count)/(lymphocyte count)
Measured: within 30 days before surgery
To assess the preoperative high-sensitivity modified Glasgow prognostic score (Hs-mGPS) and prognostic nutrition index (PNI) as prognostic tools in primary RPS patients
The high-sensitivity modified Glasgow prognostic score (Hs-mGPS) will be defined as numeric value 0 - 2 according to following criteria based on C-reactive protein (CRP) and serum albumin levels:
Score 0: CRP level ≤ 0.3 mg/dl and albumin ≥ 3.5 g/dl, Score 1: CRP level > 0.3 mg/dl and albumin ≥ 3.5 g/dl, Score 3: CRP level > 0.3 mg/ dl and albumin < 3.5 g/dl.
The prognostic nutrition index (PNI) will be calculated based on previously published and validated formula:
PNI =10× serum albumin (g/dl)+0.005× lymphocyte count (per mm^3)
Measured: within 30 days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start2 Dec 2022
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Retroperitoneal SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Ramanović, M.D., Principal investigator, Institute of Oncology Ljubljana, Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631379
- Sponsor's protocol ID
- ERID-KSOPKR-0081/2020
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided
Publications
Previtali P, Fiore M, Colombo J, Arendar I, Fumagalli L, Pizzocri M, Colombo C, Rampello NN, Mariani L, Gronchi A, Codazzi D. Malnutrition and Perioperative Nutritional Support in Retroperitoneal Sarcoma Patients: Results from a Prospective Study. Ann Surg Oncol. 2020 Jun;27(6):2025-2032. doi: 10.1245/s10434-019-08121-0. Epub 2019 Dec 17.
PubMed 31848820Stiller CA, Trama A, Serraino D, Rossi S, Navarro C, Chirlaque MD, Casali PG; RARECARE Working Group. Descriptive epidemiology of sarcomas in Europe: report from the RARECARE project. Eur J Cancer. 2013 Feb;49(3):684-95. doi: 10.1016/j.ejca.2012.09.011. Epub 2012 Oct 15.
PubMed 23079473Arends J, Baracos V, Bertz H, Bozzetti F, Calder PC, Deutz NEP, Erickson N, Laviano A, Lisanti MP, Lobo DN, McMillan DC, Muscaritoli M, Ockenga J, Pirlich M, Strasser F, de van der Schueren M, Van Gossum A, Vaupel P, Weimann A. ESPEN expert group recommendations for action against cancer-related malnutrition. Clin Nutr. 2017 Oct;36(5):1187-1196. doi: 10.1016/j.clnu.2017.06.017. Epub 2017 Jun 23.
PubMed 28689670Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
PubMed 30181091Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Donini LM, Busetto L, Bischoff SC, Cederholm T, Ballesteros-Pomar MD, Batsis JA, Bauer JM, Boirie Y, Cruz-Jentoft AJ, Dicker D, Frara S, Fruhbeck G, Genton L, Gepner Y, Giustina A, Gonzalez MC, Han HS, Heymsfield SB, Higashiguchi T, Laviano A, Lenzi A, Nyulasi I, Parrinello E, Poggiogalle E, Prado CM, Salvador J, Rolland Y, Santini F, Serlie MJ, Shi H, Sieber CC, Siervo M, Vettor R, Villareal DT, Volkert D, Yu J, Zamboni M, Barazzoni R. Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obes Facts. 2022;15(3):321-335. doi: 10.1159/000521241. Epub 2022 Feb 23.
PubMed 35196654Hou T, Guo T, Nie R, Hong D, Zhou Z, Zhang X, Liang Y. The prognostic role of the preoperative systemic immune-inflammation index and high-sensitivity modified Glasgow prognostic score in patients after radical operation for soft tissue sarcoma. Eur J Surg Oncol. 2020 Aug;46(8):1496-1502. doi: 10.1016/j.ejso.2020.05.026. Epub 2020 Jun 11.
PubMed 32576479Yang Z, Zhang B, Hou L, Xie Y, Cao X. Pre-operative prognostic nutritional index predicts the outcomes for triple-negative breast cancer. Tumour Biol. 2014 Dec;35(12):12165-71. doi: 10.1007/s13277-014-2524-6. Epub 2014 Aug 30.
PubMed 25172099
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Body Composition, Nutritional Status and Inflammatory Markers on Survival and Postoperative Outcome in Patients Operated on for Primary Retroperitoneal Sarcoma: Report From Institute of Oncology Ljubljana
- ClinicalTrials.gov ID
- NCT05631379
- Acronym / sponsor ID
- ERID-KSOPKR-0081/2020
- Conditions
- Retroperitoneal Sarcoma, Body Composition, Malnutrition, Sarcopenia, Sarcopenic Obesity, Myosteatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity.
Detailed description
Retroperitoneal sarcomas (RPS) are rare neoplasms of mesenchymal origin with estimated crude incidence of 0.3 cases per 100000 inhabitants per year. The most common histologic subtypes are well-differentiated and dedifferentiated liposarcoma and leiomyosarcoma, accounting for 42% and 26% of cases, respectively. RPS are optimally managed in multidisciplinary settings in specialized sarcoma centers. Surgical resection with an adequate margin of normal tissue is the cornerstone of curative therapy and en bloc surgical resection of localized tumors is the recommended surgical approach. This "extended" surgical approach (including resection of adjacent organs), is optimal for reducing local recurrence and improving overall survival.
Cancer patients undergoing surgical treatment face number of challenges which negatively impact their nutritional status. Patients are usually in catabolic state, which together with ongoing proteolysis and lipolysis as well as decreased protein synthesis contribute to development of cancer - associated cachexia. Most important nutritional disorders in these patients are malnutrition, sarcopenia, cancer cachexia. On the other side, often under-recognized, sarcopenic obesity is gaining attention in clinical and research settings.
The association of malnutrition and poor postoperative outcome has been demonstrated in patients with various cancer locations. Malnourished patients reportedly have longer length of postoperative stay (LOS), higher rates of 30-day mortality, infection rate, sepsis, reoperation, increased number of cardiopulmonary complications. Diagnostic process of malnutrition has been a topic of debate considering inconsistency in diagnostic methodology and criteria. Global Leadership Initiative on Malnutrition (GLIM) addressed this problem and recommended a new diagnostic scheme for malnutrition, in form of consensus report incorporating previous finding and recommendations from world leading clinical nutrition societies. To our knowledge, no study validated GLIM criteria in patients with primary RPS.
Sarcopenia is clinical syndrome characterized by generalized skeletal muscle mass loss, loss of strength and function (performance). Sarcopenia has been associated with lower survival rate and proved to be an independent predictor of survival in patients with breast cancer, pancreatic adenocarcinoma, hepatocellular carcinoma, and melanoma. There is a lack of studies investigating the impact of sarcopenia on survival and postoperative outcome in patients with soft-tissue sarcoma (STS), including retroperitoneal sarcoma. Similarly to malnutrition diagnosis, there is an evident inconsistency and confusion in diagnostic criteria and tools used to define and characterize sarcopenia in clinical practice and research. However, recently the European Working Group on Sarcopenia in Older People (EWGSOP2) published updated findings in form of Revised European Consensus. The Working Group proposed new recommendation, among which are those related to establishing specific cut-off points for body composition (primarily skeletal muscle quantity and quality) measures that identify and characterize sarcopenia.
Sarcopenic obesity (SO) is co-existence of sarcopenia and excess adiposity. Recent expert consensus of The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) will be followed for definition and diagnostic criteria for SO.
Myosteatosis is ectopic adipose tissue infiltration in skeletal muscle. Intermuscular adipose tissue can be quantified using CT scans by low muscle radiodensity. CT-derived myosteatosis contributes to impaired glucose metabolism, including insulin resistance, type 2 diabetes mellitus, and inflammation. Additionally, it may increase the risk for dyslipidemia. Myosteatosis may predict oncologic and postoperative outcome in primary RPS patients.
Patients with primary RPS are in a great risk for malnutrition, sarcopenia and cachexia for the number of reasons: requirement for demanding abdominal surgery in their management, catabolic tumor effects, long period before diagnosis of RPS and tumor size (approximately 15 cm). Due to their rarity, it is still unclear how preoperative nutritional status and body composition impact outcome of patients with primary RPS.
STUDY DESIGN DATA COLLECTION Patient's histories including the anaesthetician's preoperative reports, surgeon's operative reports, hospital records, and follow-up data will be collected. Paper and electronic data archive of Institute of Oncology Ljubljana Patient Data Information System will be used.
The following preoperative clinical data will be acquired: age, sex, preoperative weight, height, significant weight loss, appetite loss and weakness. CT reports will be also acquired for analysis as well as histopathological diagnosis (subtype), stage, grade and tumor size.
The preoperative laboratory data, including absolute counts of leukocytes, neutrophils, lymphocytes, monocytes and platelets, CRP, and albumin levels will be assessed. Data will be deidentified and whenever possible all measures to conceal patient identifiers and maintain patient confidentiality will be taken.
STATISTICAL CONSIDERATIONS The data will be presented using appropriate summary statistics: mean, median, standard deviation for continuous variables and percentages and frequencies for categorical variables. Kaplan-Meier method will be used for survival curves analysis and differences between survival rates compared using the log-rank test. The independent prognostic variables for survival (OS and LRFS) will be identified using Cox proportional hazard model (hazard ratio, 95% confidence interval, p value).
ETHICS The study was approved by Slovenian National Medical Ethics Committee, Institute of Oncology Ljubljana Review Board and Institute of Oncology Ljubljana Ethical Committee. The need to obtain informed consent from participants was waived.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All patients meeting inclusion criteria | – | Diagnostic Test: GLIM malnutrition criteria, Diagnostic Test: Prognostic Nutritional Index (PNI), Diagnostic Test: The high-sensitivity modified Glasgow prognostic scoreAll patients meeting inclusion criteria |
| Subgroup of patients with available preoperative CT/MRI scans | – | Other: Measurement of body composition with computed tomography (CT), Diagnostic Test: GLIM malnutrition criteria, Diagnostic Test: EWGSOP2 sarcopenia criteria, Diagnostic Test: ESPEN-EASO criteria for sarcopenic obesity, Diagnostic Test: Prognostic Nutritional Index (PNI), Diagnostic Test: The high-sensitivity modified Glasgow prognostic scoreSubgroup of patients with available preoperative CT/MRI scans will be detected and body composition measurements will be assessed min order to detect nutrition-related syndromes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020
Key inclusion criteria (2 listed)
- Patients aged above 18 years old
- Patients with primary localized RPS or pelvic sarcoma operated at Surgical Department of Institute of Oncology in Ljubljana
Key exclusion criteria (6 listed)
- Patients with Gastrointestinal Stromal Tumors (GISTs) and Retroperitoneal desmoid-type fibromatosis (DF)
- Patients with visceral sarcomas (arising from visceral organ i.e., gastrointestinal, and genitourinary tracts sarcoma)
- Patients with benign retroperitoneal / pelvic tumors
- Patients with residual RPS operated at another hospital
- Patients with present recurrent, secondary, and metastatic RPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of body composition with computed tomography (CT)The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), muscle radiation attenuation (MRA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) | Other | Subgroup of patients with available preoperative CT/MRI scans |
| GLIM malnutrition criteriaGLIM criteria (Global Leadership Initiative on Malnutrition) will be applied to assess malnutrition | Diagnostic test | All patients meeting inclusion criteria, Subgroup of patients with available preoperative CT/MRI scans |
| EWGSOP2 sarcopenia criteriaEWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia | Diagnostic test | Subgroup of patients with available preoperative CT/MRI scans |
| ESPEN-EASO criteria for sarcopenic obesityThe European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) consensus criteria from 2018 will be applied to assess sarcopenic obesity | Diagnostic test | Subgroup of patients with available preoperative CT/MRI scans |
| Prognostic Nutritional Index (PNI)Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count | Diagnostic test | All patients meeting inclusion criteria, Subgroup of patients with available preoperative CT/MRI scans |
| The high-sensitivity modified Glasgow prognostic scoreThe high-sensitivity modified Glasgow prognostic score (Hs-mGPS) is an inflammation-based score consisted of C-reactive protein level and serum albumin | Diagnostic test | All patients meeting inclusion criteria, Subgroup of patients with available preoperative CT/MRI scans |
Primary outcome
Postoperative complications
Time frame: within 30 days after surgery
Complications graded by Clavien-Dindo Complication Classification System
Local recurrence rate
Time frame: From date of surgery until the date of first documented local progression assessed until June 2020
A postoperative local recurrence will be defined by biopsy-proven or radiographic evidence of local recurrent disease
Mortality
Time frame: Length of survival after surgery until June 2020 (up to 130 months)
Overall survival (OS) will be defined as the time between the date of the operation to the date of death from any cause or last follow-up (according to medical records and using telephone contacts)
11 secondary outcomes
Length of hospital stay
Time frame: up to 90 days after surgery
Major postoperative morbidity
Time frame: within 90 days after surgery
Prevalence of preoperative malnutrition in primary RPS patients
Time frame: within 30 days before surgery
Prevalence of preoperative sarcopenia in primary RPS patients
Time frame: within 30 days before surgery
To evaluate the impact of skeletal muscle area (SMA) on the prognosis of patients with primary RPS
Time frame: through study completion, an average of 6 months
To evaluate the impact of the muscle radiation attenuation (MRA) on the prognosis of patients with primary RPS
Time frame: through study completion, an average of 6 months
To evaluate the impact of visceral adipose tissue (VAT) on the prognosis of patients with primary RPS
Time frame: through study completion, an average of 6 months
To evaluate the impact of subcutaneous adipose tissue (SAT) on the prognosis of patients with primary RPS
Time frame: through study completion, an average of 6 months
To evaluate the impact of visceral-to-subcutaneous adipose tissue area ratio (VSR) on the prognosis of patients with primary RPS
Time frame: through study completion, an average of 6 months
To assess the impact of complete blood count based systemic inflammatory markers: NLR, PLR and SII on the prognosis of patients with primary RPS
Time frame: within 30 days before surgery
To assess the preoperative high-sensitivity modified Glasgow prognostic score (Hs-mGPS) and prognostic nutrition index (PNI) as prognostic tools in primary RPS patients
Time frame: within 30 days before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Background: PubMed 31848820Previtali P, Fiore M, Colombo J, Arendar I, Fumagalli L, Pizzocri M, Colombo C, Rampello NN, Mariani L, Gronchi A, Codazzi D. Malnutrition and Perioperative Nutritional Support in Retroperitoneal Sarcoma Patients: Results from a Prospective Study. Ann Surg Oncol. 2020 Jun;27(6):2025-2032. doi: 10.1245/s10434-019-08121-0. Epub 2019 Dec 17.
- Background: PubMed 23079473Stiller CA, Trama A, Serraino D, Rossi S, Navarro C, Chirlaque MD, Casali PG; RARECARE Working Group. Descriptive epidemiology of sarcomas in Europe: report from the RARECARE project. Eur J Cancer. 2013 Feb;49(3):684-95. doi: 10.1016/j.ejca.2012.09.011. Epub 2012 Oct 15.
- Background: PubMed 28689670Arends J, Baracos V, Bertz H, Bozzetti F, Calder PC, Deutz NEP, Erickson N, Laviano A, Lisanti MP, Lobo DN, McMillan DC, Muscaritoli M, Ockenga J, Pirlich M, Strasser F, de van der Schueren M, Van Gossum A, Vaupel P, Weimann A. ESPEN expert group recommendations for action against cancer-related malnutrition. Clin Nutr. 2017 Oct;36(5):1187-1196. doi: 10.1016/j.clnu.2017.06.017. Epub 2017 Jun 23.
- Background: PubMed 30181091Cederholm T, Jensen GL, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, Baptista G, Barazzoni R, Blaauw R, Coats A, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren MAE, Siltharm S, Singer P, Tappenden K, Velasco N, Waitzberg D, Yamwong P, Yu J, Van Gossum A, Compher C; GLIM Core Leadership Committee; GLIM Working Group. GLIM criteria for the diagnosis of malnutrition - A consensus report from the global clinical nutrition community. Clin Nutr. 2019 Feb;38(1):1-9. doi: 10.1016/j.clnu.2018.08.002. Epub 2018 Sep 3.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 35196654Donini LM, Busetto L, Bischoff SC, Cederholm T, Ballesteros-Pomar MD, Batsis JA, Bauer JM, Boirie Y, Cruz-Jentoft AJ, Dicker D, Frara S, Fruhbeck G, Genton L, Gepner Y, Giustina A, Gonzalez MC, Han HS, Heymsfield SB, Higashiguchi T, Laviano A, Lenzi A, Nyulasi I, Parrinello E, Poggiogalle E, Prado CM, Salvador J, Rolland Y, Santini F, Serlie MJ, Shi H, Sieber CC, Siervo M, Vettor R, Villareal DT, Volkert D, Yu J, Zamboni M, Barazzoni R. Definition and Diagnostic Criteria for Sarcopenic Obesity: ESPEN and EASO Consensus Statement. Obes Facts. 2022;15(3):321-335. doi: 10.1159/000521241. Epub 2022 Feb 23.
- Background: PubMed 32576479Hou T, Guo T, Nie R, Hong D, Zhou Z, Zhang X, Liang Y. The prognostic role of the preoperative systemic immune-inflammation index and high-sensitivity modified Glasgow prognostic score in patients after radical operation for soft tissue sarcoma. Eur J Surg Oncol. 2020 Aug;46(8):1496-1502. doi: 10.1016/j.ejso.2020.05.026. Epub 2020 Jun 11.
- Background: PubMed 25172099Yang Z, Zhang B, Hou L, Xie Y, Cao X. Pre-operative prognostic nutritional index predicts the outcomes for triple-negative breast cancer. Tumour Biol. 2014 Dec;35(12):12165-71. doi: 10.1007/s13277-014-2524-6. Epub 2014 Aug 30.
- Individual participant dataSharing planned: Undecided. Not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Ramanović, M.D. principal investigator
Institute of Oncology Ljubljana, Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retroperitoneal Sarcoma and Body Composition, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: within 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631379, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.