Following People With Colitis Caused by Cancer Immunotherapy Drugs

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who developed colitis (inflammation of the large bowel) after treatment with immune checkpoint inhibitors. It follows them over time.

Age

18 years or older

Sex

All sexes can join

Disease stage

Colitis proven by at least one colonoscopy (visible and/or under the microscope) after starting immune checkpoint inhibitor treatment

Earlier treatment

At least one cycle of immune checkpoint inhibitors before the bowel symptoms began

Main reasons for not taking part

• Colitis or inflammatory bowel disease before the checkpoint inhibitor treatment

The registry criteria, word for word

What the trial wants to find out

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 group in the trial

• Newly diagnosed of CIC patients, with a proven endoscopic and histological diagnosis

  The study will include all patients developing colitis (diagnosed with endoscopy and/or histological examination) after at least one administration of a checkpoint inhibitor therapy for advanced cancer. Patients with a previous diagnosis of IBD (before cancer onset or before immunotherapy beginning) will be excluded, as well as patients with a previous diagnosis of other forms of colitis (other than IBD).