Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a condition called immune checkpoint inhibitor-induced colitis (CIC), which can happen in some patients receiving treatment for advanced melanoma, lung cancer, or kidney cancer. The goal of the study is to gather information about this condition, including how it affects patients and the best ways to manage it. Researchers will be looking at both past cases and new patients diagnosed with CIC to understand the symptoms and responses to treatment better.

To participate in this trial, you need to be at least 18 years old and have received immune checkpoint inhibitors, which are a type of cancer treatment, before experiencing symptoms in your intestines. You also need to have had a colonoscopy that shows signs of colitis after starting this treatment. If you decide to join, researchers will collect detailed information about your health, treatment, and how you respond to the therapy. This study is currently recruiting participants across various centers in Europe, aiming to improve care for those affected by this rare but important condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age ≥ 18 years;
• • patients able to provide informed consent or who have already given leave of use of their data for research in the retrospective part; waiving of the informed consent may be applied if national regulations allow to do so;
• • patients who have undergone at least one cycle of immune checkpoint inhibitors before the onset of intestinal symptoms;
• • patients with at least one colonoscopy showing macroscopical and/or histological colitis after commencement of immune checkpoint inhibitors therapy; for retrospective patients only, a follow-up of at least 12 months, unless death occurred before.
• Exclusion Criteria:
• • Evidence of colitis/inflammatory bowel disease prior to checkpoint inhibitors administration