NCT06899789Recruiting
Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- 29 Jul 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Diseases
- Kidney cancer, Melanoma, Lung cancer
- NCT number
- NCT06899789
What you commit to
- Study type: Observational
- Planned participants: 250
- From 29 Jul 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of colitis/inflammatory bowel disease prior to checkpoint inhibitors administration
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.