Multi-omics early-warning system to detect organ damage during cancer immunotherapy
Official title: Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics
Run by Hebei Medical University Fourth Hospital · NCT07131007 · Data updated 2026-11-12
This project will try to use multi-omics data and routine clinical measurements from people receiving immune checkpoint inhibitors to build an early-warning system that flags organ damage.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | January 1, 2029 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07131007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cancer who are currently receiving immune checkpoint inhibitor therapy and who do not have active severe autoimmune disease, severe organ dysfunction, active infection, or pregnancy/lactation are the intended participants.
✕Probably not a fit
Patients with active severe autoimmune disease, uncontrolled organ failure, active infection, pregnancy or breastfeeding, or allergy to treatment components are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project integrates genomics, transcriptomics, proteomics, metabolomics and routine biochemical and hemodynamic data from patients treated with immune checkpoint inhibitors. Researchers will mine databases and collect monitoring samples to identify molecular and clinical patterns associated with immune-related organ damage. Those signals will be combined into a risk-based early-warning algorithm and its clinical value will be verified against patient outcomes. The system aims to provide timely alerts to clinicians to improve the safety of cancer immunotherapy.
Why it matters
Potential benefit: If successful, it could detect organ injury earlier so clinicians can intervene sooner and reduce severe immune-related adverse events.
How similar studies have gone: Related multi-omics efforts to predict immune-related adverse events have shown promising early results, but fully validated clinical early-warning systems remain largely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: · Patients with cancer who are receiving immune checkpoint inhibitor treatment. Exclusion Criteria: * Active phase of severe autoimmune disease. * Severe organ dysfunction. * Presence of active infection. * Pregnancy or lactation. * Allergy to drug components.
Where it's running
-
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.