Clinical trial · Observational
GI Complications in Cancer Immunotherapy Patients
NCT02784366CI-TRIAL-00057555unknownClinicalTrials.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 purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cancer immunotherapy patients - no GI side effect
- description
- Cancer immunotherapy patients who do not develop GI side effects.
- label
- Cancer immunotherapy patients - develop GI side effects
- description
- Cancer immunotherapy patients who develop GI side effects
Primary outcomes (2)
- measure
- GI disease activity
- timeFrame
- 12 weeks
- description
- To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms.
- measure
- Biospecimen collection
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of cancer * Currently undergoing or have undergone immunotherapy Exclusion Criteria: * History of a total colectomy * History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease) * History of colitis on chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.