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

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.

NCT Number	NCT06899789
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, Ileo-colitis, Immune Mediated-colitis
Enrollment	250 participants
Start Date	2022-07-29
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-28