Actively Recruiting
Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-03-28
250
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 rarity of this condition. The study is observational including both retrospective and newly diagnosed cases of CIC with an endoscopically/histologically-proven diagnosis. Detailed characteristics will be collected, with the aim of classifying the disorders from a clinical, endoscopic, and pathological point of view. Age, sex, localisation, and histology of tumour, stage of tumour, oncological response to immune checkpoint inhibitors-induced colitis, colonoscopy, histology, inflammatory parameters, and clinical manifestations will be assessed for each patient, as well as therapy and outcome. The study will consist of 2 part: the first one will be retrospective, while the second one will be prospective al will include all incident patients diagnosed with CIC during the enrolment period.
CONDITIONS
Official Title
Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide informed consent or prior consent for data use in retrospective cases
- Received at least one cycle of immune checkpoint inhibitors before intestinal symptoms
- At least one colonoscopy showing macroscopic or histological colitis after starting immune checkpoint inhibitors
- For retrospective patients, a follow-up of at least 12 months unless death occurred earlier
You will not qualify if you...
- Evidence of colitis or inflammatory bowel disease before starting immune checkpoint inhibitors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
M
Marco V Lenti, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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