Lung Cancer (Non-Small Cell)NCT07500376
Multimodal Nutritional and Sarcopenia Assessment for Risk Stratification in Lung Cancer Surgery
An observational study of Lung Cancer (Non-Small Cell) and Sarcopenia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to evaluate the prognostic value of multimodal nutritional status and sarcopenia assessment in patients undergoing lung cancer surgery. Postoperative complications, mortality, and prolonged hospital stay remain major clinical concerns in thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (Non-Small Cell), Sarcopenia, Malnutrition Severe
- What is being tested?
- Observational Assessment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 Mar 2027
- 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: Adult patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer at a tertiary thoracic surgery center will be included. All participants will be prospectively enrolled and evaluated preoperatively for nutritional status and sarcopenia using clinical, biochemical, and imaging-based assessments.
Who may be able to join
- Age ≥18 years
- Patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer
- Availability of preoperative thoracic computed tomography (CT) within 30 days before surgery
- Completion of preoperative nutritional assessment and ultrasonographic muscle measurements
- Ability to provide written informed consent
Who cannot join
- Receipt of neoadjuvant chemotherapy, immunotherapy, or radiotherapy
- Emergency surgery
- Pneumonectomy
- Combined resection of another organ during the same procedure
- Inadequate or non-evaluable imaging or measurement data
- Immunosuppressive therapy or presence of advanced/metastatic disease
- Significant thoracic deformity or prior conditions interfering with muscle measurements
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ondokuz Mayis University Faculty of Medicine, Department of Thoracic Surgery
Samsun, Samsun
Caner İşevi, MD, +903623121919 ext. 4240, drcanerisevi@gmail.com
About this study
Official title: Prognostic Value of Multimodal Nutritional Status and Sarcopenia Assessment for Postoperative Risk Stratification in Patients Undergoing Lung Cancer Surgery: A Prospective Cohort Study
This prospective observational cohort study aims to evaluate the prognostic value of multimodal nutritional status and sarcopenia assessment in patients undergoing lung cancer surgery. Postoperative complications, mortality, and prolonged hospital stay remain major clinical concerns in thoracic surgery. Although malnutrition and sarcopenia are recognized as important determinants of surgical outcomes, their combined and multidimensional evaluation has not been sufficiently studied.
Adult patients undergoing anatomical lung resection for primary lung cancer will be included. Nutritional status will be assessed using serum biomarkers, inflammatory indices, and validated clinical nutritional scores. Sarcopenia will be evaluated using computed tomography-based muscle mass and density measurements, as well as ultrasonographic muscle thickness.
Read more
These parameters will be analyzed in relation to postoperative complications, intensive care unit (ICU) requirement, length of hospital stay, and mortality. Multivariable analyses will be performed to identify independent predictors, and a combined risk stratification model will be developed.
This study aims to improve preoperative risk assessment and to support personalized perioperative management strategies, including identification of patients who may benefit from targeted nutritional optimization and prehabilitation.
Read the detailed description
This prospective, single-center observational cohort study will be conducted at Ondokuz Mayis University, Department of Thoracic Surgery. The study aims to investigate the combined prognostic impact of nutritional status and sarcopenia on postoperative outcomes in patients undergoing lung cancer surgery.
Postoperative morbidity and mortality remain significant concerns following lung cancer surgery. Current risk stratification approaches mainly focus on age, comorbidities, and pulmonary function, while modifiable biological factors such as nutritional status and sarcopenia are not systematically integrated into routine assessment.
In this study, nutritional status will be evaluated using serum biomarkers (including albumin and inflammatory markers), inflammatory indices such as CRP/albumin ratio, and validated clinical nutritional scores (including NRS-2002, CONUT, PNI, and NRI). Dietitian-based assessments will include bioimpedance analysis, handgrip strength, and functional performance tests.
Sarcopenia will be assessed using preoperative computed tomography (CT) by measuring skeletal muscle area, muscle density, and pectoralis muscle index. Ultrasonographic measurements of pectoral muscle thickness will also be obtained. Sarcopenia will be defined according to established international consensus criteria.
Postoperative outcomes including complications, intensive care unit requirement, length of hospital stay, and short-term mortality will be recorded. Complications will be classified using a standardized severity grading system.
Multivariable statistical analyses will be performed to identify independent predictors of adverse outcomes. The combined effect of malnutrition and sarcopenia will be evaluated, and a multimodal risk stratification model will be developed. Model performance will be assessed using discrimination and calibration metrics.
The study is expected to provide a clinically applicable and reproducible multimodal risk assessment framework. This approach may improve patient selection, support perioperative decision-making, and facilitate targeted nutritional and prehabilitation strategies in lung cancer surgery.
- Being tested
- Observational Assessment
- Keywords
- lung cancer surgery, sarcopenia, nutritional status, malnutrition, risk stratification
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Sarcopenia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational AssessmentOther
Participants will undergo standard preoperative clinical evaluation including nutritional assessment, laboratory measurements, and imaging-based body composition analysis as part of routine care. No experimental intervention or treatment is administered. All data are collected observationally without influencing clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer Surgery Cohort | Adult patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer will be prospectively enrolled. Preoperative nutritional status and sarcopenia will be assessed using biochemical markers, validated nutritional scores, and imaging-based muscle measurements. Patients will be followed for postoperative outcomes including complications, intensive care unit requirement, length of hospital stay, and mortality. Receives: Other: Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications (30-day, Clavien-Dindo classification)
Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification system. Major complications are defined as Grade III or higher. This outcome will be analyzed as both overall complication rate and major complication rate.
Measured: Within 30 days after surgery
Secondary outcomes (1)
Length of hospital stay
Total number of days from the date of surgery to hospital discharge.
Measured: Postoperative period (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start15 Mar 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Non-Small Cell)Studies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500376
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/889
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Multimodal Nutritional Status and Sarcopenia Assessment for Postoperative Risk Stratification in Patients Undergoing Lung Cancer Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07500376
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/889
- Keywords
- lung cancer surgery, sarcopenia, nutritional status, malnutrition, risk stratification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 30 Mar 2026 (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 prospective observational cohort study aims to evaluate the prognostic value of multimodal nutritional status and sarcopenia assessment in patients undergoing lung cancer surgery. Postoperative complications, mortality, and prolonged hospital stay remain major clinical concerns in thoracic surgery. Although malnutrition and sarcopenia are recognized as important determinants of surgical outcomes, their combined and multidimensional evaluation has not been sufficiently studied.
Adult patients undergoing anatomical lung resection for primary lung cancer will be included. Nutritional status will be assessed using serum biomarkers, inflammatory indices, and validated clinical nutritional scores. Sarcopenia will be evaluated using computed tomography-based muscle mass and density measurements, as well as ultrasonographic muscle thickness.
These parameters will be analyzed in relation to postoperative complications, intensive care unit (ICU) requirement, length of hospital stay, and mortality. Multivariable analyses will be performed to identify independent predictors, and a combined risk stratification model will be developed.
This study aims to improve preoperative risk assessment and to support personalized perioperative management strategies, including identification of patients who may benefit from targeted nutritional optimization and prehabilitation.
Detailed description
This prospective, single-center observational cohort study will be conducted at Ondokuz Mayis University, Department of Thoracic Surgery. The study aims to investigate the combined prognostic impact of nutritional status and sarcopenia on postoperative outcomes in patients undergoing lung cancer surgery.
Postoperative morbidity and mortality remain significant concerns following lung cancer surgery. Current risk stratification approaches mainly focus on age, comorbidities, and pulmonary function, while modifiable biological factors such as nutritional status and sarcopenia are not systematically integrated into routine assessment.
In this study, nutritional status will be evaluated using serum biomarkers (including albumin and inflammatory markers), inflammatory indices such as CRP/albumin ratio, and validated clinical nutritional scores (including NRS-2002, CONUT, PNI, and NRI). Dietitian-based assessments will include bioimpedance analysis, handgrip strength, and functional performance tests.
Sarcopenia will be assessed using preoperative computed tomography (CT) by measuring skeletal muscle area, muscle density, and pectoralis muscle index. Ultrasonographic measurements of pectoral muscle thickness will also be obtained. Sarcopenia will be defined according to established international consensus criteria.
Postoperative outcomes including complications, intensive care unit requirement, length of hospital stay, and short-term mortality will be recorded. Complications will be classified using a standardized severity grading system.
Multivariable statistical analyses will be performed to identify independent predictors of adverse outcomes. The combined effect of malnutrition and sarcopenia will be evaluated, and a multimodal risk stratification model will be developed. Model performance will be assessed using discrimination and calibration metrics.
The study is expected to provide a clinically applicable and reproducible multimodal risk assessment framework. This approach may improve patient selection, support perioperative decision-making, and facilitate targeted nutritional and prehabilitation strategies in lung cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Surgery Cohort | – | Other: Observational AssessmentAdult patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer will be prospectively enrolled. Preoperative nutritional status and sarcopenia will be assessed using biochemical markers, validated nutritional scores, and imaging-based muscle measurements. Patients will be followed for postoperative outcomes including complications, intensive care unit requirement, length of hospital stay, and mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer at a tertiary thoracic surgery center will be included. All participants will be prospectively enrolled and evaluated preoperatively for nutritional status and sarcopenia using clinical, biochemical, and imaging-based assessments.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patients undergoing anatomical lung resection (lobectomy or segmentectomy) for primary lung cancer
- Availability of preoperative thoracic computed tomography (CT) within 30 days before surgery
- Completion of preoperative nutritional assessment and ultrasonographic muscle measurements
- Ability to provide written informed consent
Key exclusion criteria (8 listed)
- Receipt of neoadjuvant chemotherapy, immunotherapy, or radiotherapy
- Emergency surgery
- Pneumonectomy
- Combined resection of another organ during the same procedure
- Inadequate or non-evaluable imaging or measurement data
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 |
|---|---|---|
| Observational AssessmentParticipants will undergo standard preoperative clinical evaluation including nutritional assessment, laboratory measurements, and imaging-based body composition analysis as part of routine care. No experimental intervention or treatment is administered. All data are collected observationally without influencing clinical management. | Other | Lung Cancer Surgery Cohort |
Primary outcome
Postoperative complications (30-day, Clavien-Dindo classification)
Time frame: Within 30 days after surgery
Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo classification system. Major complications are defined as Grade III or higher. This outcome will be analyzed as both overall complication rate and major complication rate.
1 secondary outcome
Length of hospital stay
Time frame: Postoperative period (up to 30 days)
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 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Lung Cancer (Non-Small Cell) and Sarcopenia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 Jul 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 Turkey (Türkiye). 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 Caner İşevi, MD (+903623121919 ext. 4240, drcanerisevi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (30-day, Clavien-Dindo classification) (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.