Multi-omics early-warning system to detect organ damage during cancer immunotherapy
Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hebei Medical University Fourth Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT07131007 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shijiazhuang, Hebei
- Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.