The Gut Immune System During Immune Checkpoint Inhibitor Therapy

NCT04600180 · tracked via the Priya Life Science Netherlands tracker

Sponsor

University Medical Center Groningen

Phase

Observational

Started

2021-10-30

Last updated

2025-11-25

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

sigmoidoscopies and and venous blood sampling

sigmoidoscopies and and venous blood sampling: Sigmoidoscopies will be performed at baseline and during immunotherapy. During these procedures biopsies will be taken from the sigmoid and rectum. At the same timepoints, venous blood samples will be taken.

Study summary

This exploratory study aims to gain insight in gut immune system phenotypes before and after immunotherapy. After informed consent is obtained, sigmoidoscopies at baseline and during treatment with immunotherapy will be performed, During the endoscopies, biopsies from the sigmoid and rectum will be obtained. Subsequent immune cell analyses in these biopsies will be performed. Parallel to the sigmoidoscopies, venous blood samples will be obtained to monitor inflammatory markers.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Indication for treatment with anti PD1/PDL1 based immunotherapy * Written informed consent * Evaluable according to iRECIST v1.1 Exclusion Criteria: * Concomitant, chronic or infectious illness in the past 6 months causing moderate to severe colitis * Use of a medication in the past 6 months with an elevated risk of moderate to severe colitis * Gastrointestinal resection or enterostomy * Abdominal radiotherapy in the past 6 months

Primary outcome measure(s)

CD8+ T cell count in the gut mucosa — 8 weeks

Trial sites (1)

Facility	City	Region	Status
University Medical Center Groningen	Groningen	Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04600180 on ClinicalTrials.gov ↗ ← All trials in the Netherlands