The Gut Immune System During Immune Checkpoint Inhibitor Therapy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

sigmoidoscopies and and venous blood sampling

Procedure

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.

Primary outcomes

CD8+ T cell count in the gut mucosa

Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE

Acronym: DEFENCE

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Oct 23, 2020
Registry last updated: Nov 25, 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.

Published trials that share one or more normalized conditions with this study.

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