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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06899789

ICIC-ECCO

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

250 participants in 1 patient group

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

Description:

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).