Esophageal Cancer (EsC)NCT06713993
Semmelweis Esophageal Cancer Study: Noninvasive Prognostic Parameters in Patients With Oesophageal and Esophagogastric Junction Cancer
An observational study of Esophageal Cancer (EsC), run by Semmelweis University at 1 site in Hungary.
Trial summary
The objective of this observational study was to gain a deeper understanding of the epidemiology of the disease in Hungary through a broad analysis of patients with new-onset esophageal-oesophageal-stomach junction tumors, and to identify key parameters that could potentially influence the outcome of the disease and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer (EsC)
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 10 Sep 2024to 10 Sep 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary operable oesophageal and oesophagogastric junction tumours presenting to the upper gastrointestinal outpatient clinic at Semmelweis University.
Who may be able to join
- Age over 18 years
- Diagnosis of new-onset esophageal, esophagogastric junction tumor
- Elective curative surgery (open/laparoscopic regardless of surgical technique)
- Patients who have not yet received oncological treatment for their present disease
Who cannot join
- Lack of consent
- Lack of cooperation
- Contraindications for some studies: If MR scan is contraindicated, cardiac MR scan is not performed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest
Tamas Vass, +36208259039, vass.tamas@semmelweis.hu
About this study
Official title: Noninvasive Testing Procedures, Role of Biomarkers and Anticancer Treatments in Esophageal and Esophagogastric Cancer Survival and Quality of Life of Patients With Cancer of the Esophageopharyngeal and Oesophageophageophageal Junction
The objective of this observational study was to gain a deeper understanding of the epidemiology of the disease in Hungary through a broad analysis of patients with new-onset esophageal-oesophageal-stomach junction tumors, and to identify key parameters that could potentially influence the outcome of the disease and are closely correlated with morbidity and mortality. The investigators' primary objective is to identify potential factors and conditions that could be influenced and modified to enhance the disease outcome.
Main questions:
Read more
- What are the measurable changes in performance, workload, nutritional status, cardiac function, mental status in the patients studied?
- What is the time course of the changes during and after treatment?
- Which pathological parameters are associated with disease outcome and which are potential points of intervention to improve the course of the disease?
Patients will undergo a detailed physical and nutritional assessment, non-invasive imaging tests and several questionnaires in addition to the usual pre- and post-operative examinations.
Read the detailed description
Detailed assessment of the baseline cardiovascular risk and status (anthropometric data, physical status assessment, psychological and quality-of-life questionnaire, questionnaires on morbidity and cancer-related fatigue, 12-lead ECG, laboratory parameters, body composition, coronary CT, echocardiography and cardiac MR scan).
In addition to the conventional echocardiographic and cardiac MR parameters, the investigators also aimed to determine myocardial deformation, i.e. strain (Medis Suite QStrain) and T1 and T2 mapping values and late-type contrast enhancement and to investigate their prognostic role. To determine late-type contrast accumulation and to determine ECV (extracellular volume), patients will be given Gadovis contrast media.
At the same time as the cardiac MR scan (V0 and V4), a serum blood sample will be taken from the patients, from which the markers below will be measured. These markers are proteins or molecules that potentially play an important role in the development of tumour cachexia. The investigators aim to determine the prognostic significance of these parameters. (Myostatin, IGF-1 (Insulin-like Growth Factor 1), GDF-15 (Growth Differentiation Factor 15), IL-6 (Interleukin-6).
Patients are followed up for cardiovascular complications during anti-tumour treatment and are taken into care.
Patients will be assessed at first presentation, after neoadjuvant treatment, immediately before surgery, in the third week after surgery and in the 3rd, 6th, 9th, 12th postoperative months. Further follow-up is done by outpatient examination, by telephone or e-mail and through the eHealth system of Hungary (EESZT) until the end of the 3rd year.
Patient education:
The detailed patient information leaflet was prepared by the doctors involved in the development of the protocol at Semmelweis University.
Data storage and data protection:
Patients enrolled in the study will be given a unique identifier after enrolment. Only this unique identifier will be used in the research record, so the record will not be directly linked to the patient. No unique identifier (name, place and date of birth, clinical triage number, social security number, ID card number, etc.) will be included in the research form. A separate, locked document will be used to link the unique identifier to the patient. The system-generated unique identifier code is recorded by the clinician on paper, complete with name, social security number and patient´s social security number, prior to the first data entry. The same document contains the patient´s informed consent for the use of the data for scientific purposes. The database and the information and consent forms, including the patient´s signature, are stored by the institute coordinators.
Statistical methods:
Using TIBCO Statistica™ 13.4 software, the normality of continuous variables is tested using the Kolmogorov-Szmirnov test. A two-sample t-test is used for normal distribution assuming a two-tailed distribution and a one-tailed distribution for selected variables (Mandard Score for tumour regression). For variables with non-normal distribution, a Mann-Whitney U test is used as a non-parametric test. Long-term survival data are analysed using Kaplan-Meyer analysis and log rank test.The level of significance is set at p<0.05
Ethical requirements
The research design was drawn up in accordance with current legislation and the World Medical Assotiation´s Declaration of Helsinki.
- Conditions
- Esophageal Cancer (EsC)
- Keywords
- Esophageal cancer, heart failure, sarcopenia, malnutrition, frailty, heart function, Esophageal cancer surgery, cardiovascular abnormalities
- Medical subject headings
- Esophageal Neoplasms, Heart Failure, Sarcopenia, Malnutrition, Frailty, Cardiovascular Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac function: cardiac MR scan
Assessment of cardiac function by cardiac MR scan before starting treatment, after surgery and at postoperative month 12.
Measured: From enrollment to the 12th postoperative month
Changes in coronary status: coronary CT scan
Assessment of coronary status by coronary CT scan before starting treatment, after surgery and at postoperative month 12.
Measured: From enrollment to the 12th postoperative month
Morbidity (early and long term) classified after Clavien-Dindo.
7-day and 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Measured: 30 days (until 31st postoperative day)
Early and late mortality
7-day, 30-day and 90-day mortality of each patient will be recorded
Measured: 90 days (until 91st postoperative day)
Length of hospital stay
Postoperative length of hospital stay in days.
Measured: within 45 days
Number of days spent on ICU (Intensive care unit)
Number of days observed on ICU right after operation.
Measured: within 45 days postoperative
Changes in physical performance: 6-minute walk test (6MWT)
6-minute walk test (6MWT) assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Measured: From enrollment to the 12th postoperative month
Changes in physical performance: hand grip strength test
Hand grip strength test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Measured: From enrollment to the 12th postoperative month
Changes in physical performance: time up and go test
Time up and go test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Measured: From enrollment to the 12th postoperative month
Changes in ECOG (Eastern Cooperative Oncology Group) performance status
ECOG (Eastern Cooperative Oncology Group) performance status assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Measured: From enrollment to the 12th postoperative month
Change in nutritional status, risk of malnutrition and nutritional ability: MUST (Malnutrition Universal Screening Tool)
Malnutrition Universal Screening Tool (MUST) score recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. 0-2: If a patient receives a score of 0, then they are at a low risk. A patient with a score of 1 is a medium risk and any patient with a score of 2 or higher is considered high risk.
Measured: From enrollment to the 12th postoperative month
Change in nutritional status, risk of malnutrition and nutritional ability: NRS (nutritional risk score)
NRS (nutritional risk score) recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.
From enrollment to the 12th postoperative month Score 0-3: 0: absent, 3: severe
Measured: From enrollment to the 12th postoperative month
Change in nutritional status, risk of malnutrition and nutritional ability Description: PG-SGA (Patient-Generated Subjective Global Assessment)score
PG-SGA (Patient-Generated Subjective Global Assessment) score recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. The PG-SGA allows to classify nutritional status into three categories: A= well nourished; B= suspected or moderate malnutrition; and C= severe malnutrition.
Measured: From enrollment to the 12th postoperative month
Change in nutritional status, risk of malnutrition: Bioimpedance examination
Bioimpedance examination recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.
Measured: From enrollment to the 12th postoperative month
Change in nutritional ability: swallowing test
Swallowing test recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.
Measured: From enrollment to the 12th postoperative month
Change in nutritional status: myostatin level
Measurement of myostatin level before the start of treatment, postoperatively and at postoperative month 12.
Measured: From enrollment to the 12th postoperative month
Change in nutritional status: IGF-1 level
Measurement of serum IGF-1 level before the start of treatment, postoperatively and at postoperative month 12.
Measured: From enrollment to the 12th postoperative month
Change in nutritional status: GDF-15 level
Measurement of serum GDF-15 level before the start of treatment, postoperatively and at postoperative month 12.
Measured: From enrollment to the 12th postoperative month
Change in nutritional status: IL-6 level
Measurement of serum IL-6 level before the start of treatment, postoperatively and at postoperative month 12.
Measured: From enrollment to the 12th postoperative month
Secondary outcomes (8)
Change in mental status: adherence
Completion of MAS-12 (Motivation Assessment Scale) questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months The MAS-12 total score ranges from 12 to 60 (higher score indicates higher treatment adherence)
Measured: From enrollment to the 12th postoperative month
Change in cancer related fatigue
Brief Fatigue Inventory (BFI) questionnaires at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months Scoring respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores are divided into 3 categories based on the average of each response categorized as mild (1-3), moderate (4-6), and severe (7-10).
Measured: From enrollment to the 12th postoperative month
Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).
Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded.
Measured: within 8 weeks, if adjuvant oncotherapy is needed
Change in mental status: depression
Completion of PHQ-9 (Patient Health Questionnaire-9) questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression)
Measured: From enrollment to the 12th postoperative month
Change in mental status: anxiety
GAD-7 (General Anxiety Disorder) questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety.
Measured: From enrollment to the 12th postoperative month
Change in frailty: Clinical frailty scale (CFS)
Clinical frailty scale (CFS) questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months The clinical frailty scale is a 9-point scale that quantifies frailty based on function in individual patients. It is complemented by a visual chart to assist with the classification of frailty. Higher scores indicate increased frailty and associated risks.
Measured: From enrollment to the 12th postoperative month
Change in frailty: FRAIL scale
FRAIL (Fatigue, Resistance, Ambulation, Illness, and Loss) scale questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months The FRAIL scale includes 5 components: Fatigue, Resistance, Ambulation, Illness, and Loss of weight (10). Frail scale scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status.
Measured: From enrollment to the 12th postoperative month
Change in frailty: 5-item Frailty Score
5-item Frailty Score questionnaire at first appointment, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months Scored from 0 to 5 Higher number indicates higher frailty
Measured: From enrollment to the 12th postoperative month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Sep 2024
- Primary completion30 Sep 2029 (estimated)
- Study completion10 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal Cancer (EsC)Studies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713993
- Sponsor's protocol ID
- NNGYK/18646-5/2024
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Publications
Lorusso A, Bichev D, Hogner A, Bartels P, Ballhausen A, Treese C, Biebl M, Thuss-Patience P. Prognostic Relevance of Weight and Weight Loss during Multimodal Therapy for Oesophagogastric Tumours. Curr Oncol. 2022 Apr 12;29(4):2706-2719. doi: 10.3390/curroncol29040221.
PubMed 35448195van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
PubMed 22646630Sondergaard MMA, Nordsmark M, Nielsen KM, Poulsen SH. Cardiovascular Burden and Adverse Events in Patients With Esophageal Cancer Treated With Chemoradiation for Curative Intent. JACC CardioOncol. 2021 Dec 21;3(5):711-721. doi: 10.1016/j.jaccao.2021.10.002. eCollection 2021 Dec.
PubMed 34988480Eads JR. Cardiovascular Concerns in the Management of Esophageal Cancer Patients. JACC CardioOncol. 2021 Dec 21;3(5):722-724. doi: 10.1016/j.jaccao.2021.11.005. eCollection 2021 Dec.
PubMed 34988481
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Testing Procedures, Role of Biomarkers and Anticancer Treatments in Esophageal and Esophagogastric Cancer Survival and Quality of Life of Patients With Cancer of the Esophageopharyngeal and Oesophageophageophageal Junction
- ClinicalTrials.gov ID
- NCT06713993
- Acronym / sponsor ID
- NNGYK/18646-5/2024
- Conditions
- Esophageal Cancer (EsC)
- Keywords
- Esophageal cancer, heart failure, sarcopenia, malnutrition, frailty, heart function, Esophageal cancer surgery, cardiovascular abnormalities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 10 Sep 2034 (estimated)
- First posted
- 3 Dec 2024 (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.
The objective of this observational study was to gain a deeper understanding of the epidemiology of the disease in Hungary through a broad analysis of patients with new-onset esophageal-oesophageal-stomach junction tumors, and to identify key parameters that could potentially influence the outcome of the disease and are closely correlated with morbidity and mortality. The investigators' primary objective is to identify potential factors and conditions that could be influenced and modified to enhance the disease outcome.
Main questions:
- What are the measurable changes in performance, workload, nutritional status, cardiac function, mental status in the patients studied?
- What is the time course of the changes during and after treatment?
- Which pathological parameters are associated with disease outcome and which are potential points of intervention to improve the course of the disease?
Patients will undergo a detailed physical and nutritional assessment, non-invasive imaging tests and several questionnaires in addition to the usual pre- and post-operative examinations.
Detailed description
Detailed assessment of the baseline cardiovascular risk and status (anthropometric data, physical status assessment, psychological and quality-of-life questionnaire, questionnaires on morbidity and cancer-related fatigue, 12-lead ECG, laboratory parameters, body composition, coronary CT, echocardiography and cardiac MR scan).
In addition to the conventional echocardiographic and cardiac MR parameters, the investigators also aimed to determine myocardial deformation, i.e. strain (Medis Suite QStrain) and T1 and T2 mapping values and late-type contrast enhancement and to investigate their prognostic role. To determine late-type contrast accumulation and to determine ECV (extracellular volume), patients will be given Gadovis contrast media.
At the same time as the cardiac MR scan (V0 and V4), a serum blood sample will be taken from the patients, from which the markers below will be measured. These markers are proteins or molecules that potentially play an important role in the development of tumour cachexia. The investigators aim to determine the prognostic significance of these parameters. (Myostatin, IGF-1 (Insulin-like Growth Factor 1), GDF-15 (Growth Differentiation Factor 15), IL-6 (Interleukin-6).
Patients are followed up for cardiovascular complications during anti-tumour treatment and are taken into care.
Patients will be assessed at first presentation, after neoadjuvant treatment, immediately before surgery, in the third week after surgery and in the 3rd, 6th, 9th, 12th postoperative months. Further follow-up is done by outpatient examination, by telephone or e-mail and through the eHealth system of Hungary (EESZT) until the end of the 3rd year.
Patient education:
The detailed patient information leaflet was prepared by the doctors involved in the development of the protocol at Semmelweis University.
Data storage and data protection:
Patients enrolled in the study will be given a unique identifier after enrolment. Only this unique identifier will be used in the research record, so the record will not be directly linked to the patient. No unique identifier (name, place and date of birth, clinical triage number, social security number, ID card number, etc.) will be included in the research form. A separate, locked document will be used to link the unique identifier to the patient. The system-generated unique identifier code is recorded by the clinician on paper, complete with name, social security number and patient´s social security number, prior to the first data entry. The same document contains the patient´s informed consent for the use of the data for scientific purposes. The database and the information and consent forms, including the patient´s signature, are stored by the institute coordinators.
Statistical methods:
Using TIBCO Statistica™ 13.4 software, the normality of continuous variables is tested using the Kolmogorov-Szmirnov test. A two-sample t-test is used for normal distribution assuming a two-tailed distribution and a one-tailed distribution for selected variables (Mandard Score for tumour regression). For variables with non-normal distribution, a Mann-Whitney U test is used as a non-parametric test. Long-term survival data are analysed using Kaplan-Meyer analysis and log rank test.The level of significance is set at p<0.05
Ethical requirements
The research design was drawn up in accordance with current legislation and the World Medical Assotiation´s Declaration of Helsinki.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary operable oesophageal and oesophagogastric junction tumours presenting to the upper gastrointestinal outpatient clinic at Semmelweis University.
Key inclusion criteria (4 listed)
- Age over 18 years
- Diagnosis of new-onset esophageal, esophagogastric junction tumor
- Elective curative surgery (open/laparoscopic regardless of surgical technique)
- Patients who have not yet received oncological treatment for their present disease
Key exclusion criteria (3 listed)
- Lack of consent
- Lack of cooperation
- Contraindications for some studies: If MR scan is contraindicated, cardiac MR scan is not performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in cardiac function: cardiac MR scan
Time frame: From enrollment to the 12th postoperative month
Assessment of cardiac function by cardiac MR scan before starting treatment, after surgery and at postoperative month 12.
Changes in coronary status: coronary CT scan
Time frame: From enrollment to the 12th postoperative month
Assessment of coronary status by coronary CT scan before starting treatment, after surgery and at postoperative month 12.
Morbidity (early and long term) classified after Clavien-Dindo.
Time frame: 30 days (until 31st postoperative day)
7-day and 30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Early and late mortality
Time frame: 90 days (until 91st postoperative day)
7-day, 30-day and 90-day mortality of each patient will be recorded
Length of hospital stay
Time frame: within 45 days
Postoperative length of hospital stay in days.
Number of days spent on ICU (Intensive care unit)
Time frame: within 45 days postoperative
Number of days observed on ICU right after operation.
Changes in physical performance: 6-minute walk test (6MWT)
Time frame: From enrollment to the 12th postoperative month
6-minute walk test (6MWT) assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Changes in physical performance: hand grip strength test
Time frame: From enrollment to the 12th postoperative month
Hand grip strength test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Changes in physical performance: time up and go test
Time frame: From enrollment to the 12th postoperative month
Time up and go test assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Changes in ECOG (Eastern Cooperative Oncology Group) performance status
Time frame: From enrollment to the 12th postoperative month
ECOG (Eastern Cooperative Oncology Group) performance status assessment at the first appointment, immediately before surgery, third week postoperatively and postoperative 3. 6. 9. 12. months.
Change in nutritional status, risk of malnutrition and nutritional ability: MUST (Malnutrition Universal Screening Tool)
Time frame: From enrollment to the 12th postoperative month
Malnutrition Universal Screening Tool (MUST) score recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. 0-2: If a patient receives a score of 0, then they are at a low risk. A patient with a score of 1 is a medium risk and any patient with a score of 2 or higher is considered high risk.
Change in nutritional status, risk of malnutrition and nutritional ability: NRS (nutritional risk score)
Time frame: From enrollment to the 12th postoperative month
NRS (nutritional risk score) recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. From enrollment to the 12th postoperative month Score 0-3: 0: absent, 3: severe
Change in nutritional status, risk of malnutrition and nutritional ability Description: PG-SGA (Patient-Generated Subjective Global Assessment)score
Time frame: From enrollment to the 12th postoperative month
PG-SGA (Patient-Generated Subjective Global Assessment) score recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months. The PG-SGA allows to classify nutritional status into three categories: A= well nourished; B= suspected or moderate malnutrition; and C= severe malnutrition.
Change in nutritional status, risk of malnutrition: Bioimpedance examination
Time frame: From enrollment to the 12th postoperative month
Bioimpedance examination recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.
Change in nutritional ability: swallowing test
Time frame: From enrollment to the 12th postoperative month
Swallowing test recording at the first encounter, immediately before surgery, third week post-operatively and post-operatively 3. 6. 9. 12. months.
Change in nutritional status: myostatin level
Time frame: From enrollment to the 12th postoperative month
Measurement of myostatin level before the start of treatment, postoperatively and at postoperative month 12.
Change in nutritional status: IGF-1 level
Time frame: From enrollment to the 12th postoperative month
Measurement of serum IGF-1 level before the start of treatment, postoperatively and at postoperative month 12.
Change in nutritional status: GDF-15 level
Time frame: From enrollment to the 12th postoperative month
Measurement of serum GDF-15 level before the start of treatment, postoperatively and at postoperative month 12.
Change in nutritional status: IL-6 level
Time frame: From enrollment to the 12th postoperative month
Measurement of serum IL-6 level before the start of treatment, postoperatively and at postoperative month 12.
8 secondary outcomes
Change in mental status: adherence
Time frame: From enrollment to the 12th postoperative month
Change in cancer related fatigue
Time frame: From enrollment to the 12th postoperative month
Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).
Time frame: within 8 weeks, if adjuvant oncotherapy is needed
Change in mental status: depression
Time frame: From enrollment to the 12th postoperative month
Change in mental status: anxiety
Time frame: From enrollment to the 12th postoperative month
Change in frailty: Clinical frailty scale (CFS)
Time frame: From enrollment to the 12th postoperative month
Change in frailty: FRAIL scale
Time frame: From enrollment to the 12th postoperative month
Change in frailty: 5-item Frailty Score
Time frame: From enrollment to the 12th postoperative month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 35448195Lorusso A, Bichev D, Hogner A, Bartels P, Ballhausen A, Treese C, Biebl M, Thuss-Patience P. Prognostic Relevance of Weight and Weight Loss during Multimodal Therapy for Oesophagogastric Tumours. Curr Oncol. 2022 Apr 12;29(4):2706-2719. doi: 10.3390/curroncol29040221.
- Background: PubMed 22646630van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Background: PubMed 34988480Sondergaard MMA, Nordsmark M, Nielsen KM, Poulsen SH. Cardiovascular Burden and Adverse Events in Patients With Esophageal Cancer Treated With Chemoradiation for Curative Intent. JACC CardioOncol. 2021 Dec 21;3(5):711-721. doi: 10.1016/j.jaccao.2021.10.002. eCollection 2021 Dec.
- Background: PubMed 34988481Eads JR. Cardiovascular Concerns in the Management of Esophageal Cancer Patients. JACC CardioOncol. 2021 Dec 21;3(5):722-724. doi: 10.1016/j.jaccao.2021.11.005. eCollection 2021 Dec.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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Patient-Reported Symptom Care Versus Usual Care After Esophageal Cancer Surgery: A Single-Center Phase 3 Randomized Trial
Esophageal Cancer (EsC)
RecruitingPhase 2
A Single-arm, Open, Single-center Exploratory Study of Adebrelimab (SHR-1316) in Combination With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Esophageal Squamous Carcinoma
Esophageal Cancer (EsC)
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.
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 Esophageal Cancer (EsC), run by Semmelweis University at 1 site in Hungary.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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 Hungary. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamas Vass (+36208259039, vass.tamas@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiac function: cardiac MR scan (time frame: From enrollment to the 12th postoperative month). The study lists 19 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 NCT06713993, which also lists 4 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 24 Apr 2026.