Clinical trial · Observational
Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy.
NCT02600143CI-TRIAL-00076761COLIPIcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Genetic predisposition for immunotherapy-induced colitis
- timeFrame
- 1 week
- description
- Difference in genetic profile on 99 confirmed inflammatory bowel disease (IBD) loci between patients who develop immunotherapy-induced colitis and who do not.
Secondary outcomes (4)
- measure
- Predictive biomarkers for immunotherapy-induced colitis in stool and serum
- timeFrame
- Day 0, 21, 42, 63
- description
- Comparison of calprotectin levels in the stool and serum-levels of C reactive protein (CRP), endotoxin, citrulline, intestinal fatty acid-binding protein (I-FABP), calprotectin and interleukin 8 (IL8) between patients who develop immunotherapy-induced colitis and who do not.
- measure
- Clinical scoring system of colitis
- timeFrame
- Day -7 to 85
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with melanoma who will be treated with immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab) 2. Signed written informed consent. 3. Able to comply with the protocol. Exclusion Criteria: 1\. Patients with a pre-existing colitis (e.g. Crohn's disease, ulcerative colitis).
References
Publications (0)
Data not yet available
No reference posted for this study.