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

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

Plain Language Summary

Simplified for easier understanding

This study is following patients long-term who developed bowel inflammation (colitis) as a side effect of cancer immunotherapy drugs called checkpoint inhibitors. Researchers want to better understand how this condition unfolds over time. **You may be eligible if...** - You are 18 or older - You received at least one round of immune checkpoint inhibitor therapy (cancer immunotherapy) - You then developed bowel symptoms and had a colonoscopy confirming intestinal inflammation - You are willing to share your data for research purposes **You may NOT be eligible if...** - You had bowel inflammation or inflammatory bowel disease before starting checkpoint inhibitor treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo

Pavia, Pavia, Italy

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NCT06899789