Status:
RECRUITING
Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Immune Checkpoint Inhibitors-induced Colitis
Advanced Melanoma Skin Cancer, Non-small Cell Lung Carcinoma, Kidney Adenocarcinoma
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicentric, observational study, including all European centres willing to take part. The multicentre nature is necessary for enhancing the generalisability of our results, and due to the ...
Eligibility Criteria
Inclusion
- 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
- Evidence of colitis/inflammatory bowel disease prior to checkpoint inhibitors administration
Key Trial Info
Start Date :
July 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06899789
Start Date
July 29 2022
End Date
December 31 2026
Last Update
March 28 2025
Active Locations (1)
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1
SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo
Pavia, Pavia, Italy, 27100