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The Gut Immune System During Immune Checkpoint Inhibitor Therapy

NCT04600180 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2025-11-25

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Jacco J. de Haan, MD, PhD · University Medical Center Groningen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-30
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04600180 on ClinicalTrials.gov