Long-term follow-up of colitis caused by immune checkpoint inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentric observational study aims to gather data on patients who have developed colitis as a result of immune checkpoint inhibitors. It will include both retrospective and prospective cases, focusing on patients diagnosed with immune checkpoint inhibitors-induced colitis across various European centers. The study will collect detailed clinical, endoscopic, and pathological data to classify the disorder and assess factors such as age, sex, tumor characteristics, and treatment outcomes. The goal is to enhance understanding of this rare condition and improve patient management.

Why it matters

Who can join: the full rules

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

Where it's running

• SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo
  Pavia, Pavia, Italy Recruiting

Study contacts

• Study coordinator: Marco V Lenti, MD
• Email: M.Lenti@smatteo.pv.it
• Phone: +390382502183

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for liver failure caused by immune checkpoint inhibitors in liver cancer patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.