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

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.

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Key information

Conditions

Immune Checkpoint Inhibitors-induced Colitis Adenocarcinoma Advanced Melanoma Skin Cancer, Non-small Cell Lung Carcinoma, Kidney Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Ileo-colitis Immune Mediated-colitis Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Medicina Generale 1, Fondazione IRCCS Policlinico san Matteo

Pavia, 27100, Italy

Location status: Recruiting

Location contact

Marco V lenti, MD

CONTACT

[email protected]

+390382 502183

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco V Lenti, MD

CONTACT

[email protected]

+390382502183

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Mar 28, 2025
Registry last updated: Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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