RecruitingNCT06899789

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

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

250 participants

Start Date

Jul 29, 2022

Study Type

OBSERVATIONAL

Conditions

Immune Checkpoint Inhibitors-induced Colitis Advanced Melanoma Skin Cancer, Non-small Cell Lung Carcinoma, Kidney Adenocarcinoma Ileo-colitis Immune Mediated-colitis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria1

Evidence of colitis/inflammatory bowel disease prior to checkpoint inhibitors administration

Locations(1)

SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo

Pavia, Pavia, Italy

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NCT06899789