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Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis
Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
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
Conditions
Locations (1)
SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo
Pavia, Pavia, Italy