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RECRUITING
NCT06899789

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

Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

View on ClinicalTrials.gov

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 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2022-07-29

Completion Date

2026-12-31

Last Updated

2025-03-28

Healthy Volunteers

No

Locations (1)

SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo

Pavia, Pavia, Italy