Identification of Predictive Parameters for Colitis in Melanoma Patients Treated With Immunotherapy. (COLIPI)

May 3, 2024 updated by: University Medical Center Groningen
The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.

Study Overview

Status

Completed

Conditions

Detailed Description

Immunotherapy with immune checkpoint-inhibitors is standard treatment for patients with melanoma. However, in about 15% of patients treated with Ipilimumab a grade 3-4 colitis will occur. In programmed cell death protein 1 (PD1) inhibitors colitis is also seen as adverse event, although less prominent. We want to find a good predictive biomarker to select patients that are prone to colitis.So far no test is available that might be predictive whether a patient will develop a grade 3-4 colitis.

The study will consists of four parts: 1.) to identify a genetic profile associated with ipilimumab-induced colitis, 2.) to identify predictive (serum or fecal) biomarkers for ipilimumab-induced colitis, 3.) to study the tissue of ipilimumab-induced colitis and 4) to study the role of the gut microbiome in the development of colitis. Patients are able to participate in one, or more parts of the study.

Study Type

Observational

Enrollment (Actual)

123

Contacts and Locations

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

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

300

Description

Inclusion Criteria:

  1. Patients with melanoma who will be treated with immune checkpoint inhibitors (ipilimumab, nivolumab, pembrolizumab)
  2. Signed written informed consent.
  3. Able to comply with the protocol.

Exclusion Criteria:

1. Patients with a pre-existing colitis (e.g. Crohn's disease, ulcerative colitis).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic predisposition for immunotherapy-induced colitis
Time Frame: 1 week
Difference in genetic profile on 99 confirmed inflammatory bowel disease (IBD) loci between patients who develop immunotherapy-induced colitis and who do not.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive biomarkers for immunotherapy-induced colitis in stool and serum
Time Frame: Day 0, 21, 42, 63
Comparison of calprotectin levels in the stool and serum-levels of C reactive protein (CRP), endotoxin, citrulline, intestinal fatty acid-binding protein (I-FABP), calprotectin and interleukin 8 (IL8) between patients who develop immunotherapy-induced colitis and who do not.
Day 0, 21, 42, 63
Clinical scoring system of colitis
Time Frame: Day -7 to 85
Prediction of (severity of) colitis based on symptomatology measured with the MAYO score and BRISTOL stool scale.
Day -7 to 85
Histological assessment of colon biopsies in patients that develop colitis
Time Frame: 1 day
Immunotherapy-induced colitis will be assessed in colon biopsies when a sigmoidoscopy has to be performed for diagnostic reasons.
1 day
Analysis of the gut microbiome in stool samples
Time Frame: Day 0, 21, 42, 63
Microbiome analysis in stool collected before treatment and at 3, 6, and 9 weeks and correlation with development of immunotherapy-induced colitis.
Day 0, 21, 42, 63

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: G. A.P. Hospers, MD, PhD, UMCG

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

August 1, 2013

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimated)

November 9, 2015

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METc 2012/085

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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