NCT07192926Completed
Body Composition and Inflammatory-Metabolic Indices in Immunotherapy-Treated Metastatic Non-Small Cell Lung Cancer: The SARC-CTI Study
Body Composition and Inflammatory-Metabolic Indices as Prognostic Markers in Immunotherapy-Treated Metastatic Non-Small Cell Lung Cancer: The SARC-CTI Study
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
This retrospective, single-center observational cohort study evaluates inflammatory-metabolic, cachexia-related, and computed tomography (CT)-derived body-composition markers in patients with metastatic non-small cell lung cancer (mNSCLC) treated with immune checkpoint inhibitor (ICI)-based therapy. The study includes 155 consecutive adult patients who initiated ICI-based therapy at Ankara Etlik City Hospital between December 2022 and March 2025. Baseline assessments include the C-reactive protein-triglyceride glucose index (CTI), cachexia index (CXI), CT-derived skeletal muscle index (SMI), skeletal muscle attenuation, sarcopenia status, body weight, and clinical characteristics. The principal survival outcomes are progression-free survival (PFS) and overall survival (OS). Associations of baseline CTI and CXI with PFS and OS are evaluated using Cox proportional hazards regression models. The incremental prognostic performance of CTI and CXI beyond conventional clinical factors is further explored using discrimination, calibration, and decision-curve analyses. Early longitudinal changes in CT-derived body composition and body weight are evaluated in a landmark cohort of 140 patients with an eligible follow-up CT performed 8-12 weeks after ICI initiation. Associations of early skeletal muscle and body-weight changes with subsequent PFS and OS are assessed using landmark survival analyses. The survival data cutoff is June 11, 2026.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 155 (actual)
- First submitted
- 18 Sept 2025
- Start date
- 1 Dec 2022
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- Ankara Etlik City Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07192926
What you commit to
- Study type: Observational
- Participants enrolled: 155
- From 1 Dec 2022 to the primary completion date, 30 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Missing laboratory data required for CTI or CXI calculation.
Other
- No eligible baseline abdominal CT or inadequate image quality for L3 segmentation.
- Missing relevant body-weight/cachexia data.
- Incomplete survival follow-up.
- Absence of a usable L3 level or other clinical/imaging circumstances precluding reliable body-composition assessment.
Who the study is looking for
- Age ≥18 years.
- Histologically confirmed metastatic non-small cell lung cancer.
- Receipt of at least one dose of ICI-based systemic therapy as part of routine clinical care.
- Eligible baseline abdominal CT obtained within 30 days before ICI initiation and suitable for L3-level body-composition analysis.
- Availability of baseline clinical and laboratory data required for CTI and CXI calculation.
- Availability of body-weight/cachexia-related information and survival follow-up.
- Additional criterion for the landmark longitudinal analyses
- \- Eligible early follow-up CT performed approximately 8-12 weeks after ICI initiation and availability for landmark assessment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Etlik City Hospital Radiology Department Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Etlik City Hospital Medical Oncology Department Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.