Long-term follow-up of colitis caused by immune checkpoint inhibitors
Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis
This study looks at patients who have developed colitis from immune checkpoint inhibitors to better understand the condition and improve how it's treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06899789 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received immune checkpoint inhibitors and developed intestinal symptoms.
Not a fit: Patients with a history of colitis or inflammatory bowel disease prior to receiving immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnosis and treatment strategies for patients suffering from colitis induced by immune checkpoint inhibitors.
How similar studies have performed: While this study addresses a rare condition, similar observational studies have shown promise in understanding treatment-related adverse effects.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, Pavia
- 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
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.