NCT06915389Recruiting
Metabolomic and Lipidomic Analysis Predicts Immunotherapy-related Adverse Events in Gastric Cancer Patients
Comprehensive Plasma Metabolomic and Lipidomic Profiling for Predictive Modeling and Biomarker Discovery of Immune-Related Adverse Events in PD-1/PD-L1 Inhibitor-Treated Gastric Cancer Patients: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 8 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study comprehensively examines metabolic and lipidomic dynamics in gastric cancer patients initiating PD-1/PD-L1 inhibitor therapy, employing a longitudinal design with pre- and post-treatment patients. The primary objectives include identifying irAE-associated metabolic and lipid biomarkers, developing predictive risk models, and evaluating the prognostic value of these molecular profiles. The findings are expected to contribute significantly to personalized treatment strategies and improved clinical decision-making in immunooncology.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 22 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Qinghai Red Cross Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06915389
What you commit to
- Study type: Observational
- Planned participants: 100
- From 22 Feb 2025 to the primary completion date, 31 Dec 2026
- 1 site 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.
Other illness
- Unable to obtain an organization or due to insufficient organizational material, unable to diagnose gastric cancer
- Refusal to receive PD-1/PD-L1 inhibitor treatment
- Baseline (before immunotherapy) plasma samples are unavailable
- Combined with autoimmune diseases
- Baseline (before immunotherapy) there are severe diseases in the heart, lungs, thyroid gland and other organs
- Baseline (before immunotherapy) there are severe abnormalities in liver and kidney functions, pancreatic enzymes and other indicators
- ⑦ Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study
Who the study is looking for
- Age≥ 18 years
- ECOG PS 0-2
- Gastric cancer diagnosed by histology or cytology
- Untreatment with PD-1/PD-L1 inhibitors
- Expected survival≥3 months
- Exhibits a favorable adherence to treatment and follow-up,demonstrates compliance with the research protocol, and willingly signs the informed consent form.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qinghai Red Cross Hospital Coordinator of this site? Confirm its status | Xining | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.