NCT06899789 Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis
| NCT ID | NCT06899789 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Immune Checkpoint Inhibitors-induced Colitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-07-29 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2022-07-29 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06899789 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune Checkpoint Inhibitors-induced Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06899789 currently recruiting?
Yes, NCT06899789 is actively recruiting participants. Contact the research team at M.Lenti@smatteo.pv.it for enrollment information.
Where is the NCT06899789 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06899789 clinical trial?
NCT06899789 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 250 participants.