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

March 21, 2025 updated by: Marco Vincenzo Lenti, Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • SC Medicina Generale 1, Fondazione IRCCS Policlinico San Matteo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a histologically proven CIC or enterocolitis. Any cancer patient who is started on any available immune check-point inhibitor and developing CIC/enterocolitis will be enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is the rate of clinical remission defined as symptoms CTCAE grade 1 or less within 12 months after CIC diagnosis (at the last evaluation available when death occurs or at one year from diagnosis).
Time Frame: After baseline evaluation at the time of immune CIC diagnosis and four other evaluations after 3, 6, 9, and 12 months or until death if death occurred in the first 12 months.
The rate of remission at 12 months will be estimated together with its 95% exact binomial 95% CI. The association of a series of predefined non-collinear baseline covariates and remission will be assessed using multivariable logistic regression. Huber-White robust standard errors will be computed to account for intra-centre correlation of measures. In case of death prior to the 12-month assessment, the last available measure will be used. A sensitivity analysis of the primary endpoint may be performed using multiple imputation of the primary endpoint for those patients who do not reach the 12 months assessment due to death or loss to follow-up. The following covariates will be considered: mild colitis vs those who need immunosuppressants, age >70 years, female sex, BMI>25, number of comorbidities, type of cancer (localisation, histology, and stage), type of ICI. A sensitivity analysis of the primary endpoint will be performed as described above with death considered as a failure.
After baseline evaluation at the time of immune CIC diagnosis and four other evaluations after 3, 6, 9, and 12 months or until death if death occurred in the first 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICIC-ECCO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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