NCT02600143

Brief Summary

The aim of this trial is to identify biomarkers and genetic predisposition for the development of immune checkpoint related colitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

5.7 years

First QC Date

November 3, 2015

Last Update Submit

May 3, 2024

Conditions

MelanomaColitis

Keywords

MelanomaColitisIpilimumabNivolumabPembrolizumab

Outcome Measures

Primary Outcomes (1)

  • Genetic predisposition for immunotherapy-induced colitis

    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 Outcomes (4)

  • Predictive biomarkers for immunotherapy-induced colitis in stool and serum

    Day 0, 21, 42, 63

  • Clinical scoring system of colitis

    Day -7 to 85

  • Histological assessment of colon biopsies in patients that develop colitis

    1 day

  • Analysis of the gut microbiome in stool samples

    Day 0, 21, 42, 63

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

300

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG

Groningen, 9713 GZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Intestinal biopsies, whole blood samples, stool samples

MeSH Terms

Conditions

MelanomaColitis

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • G. A.P. Hospers, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 9, 2015

Study Start

August 1, 2013

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

NL(1)