The Gut Immune System During Immune Checkpoint Inhibitor Therapy

NCT04600180 | Active Not Recruiting

• 1 other identifier: 202000666
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Keywords

Immune Checkpoint Inhibitor; Cancer; Gut Wall

Outcome Measures

Primary Outcomes (1)

• CD8+ T cell count in the gut mucosa

  8 weeks

Study Arms (1)

Palliative treatment with immunotherapy

Procedure: sigmoidoscopies and and venous blood sampling

Interventions

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.

Palliative treatment with immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cancer and an indication for palliative treatment with immune checkpoint inhibitors.

You may qualify if:

• Indication for treatment with anti PD1/PDL1 based immunotherapy
• Written informed consent
• Evaluable according to iRECIST v1.1

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gut wall biopsies and venous blood sample

MeSH Terms

Conditions

Neoplasms

Interventions

Sigmoidoscopy

Intervention Hierarchy (Ancestors)

Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jacco J. de Haan, 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: October 19, 2020
• First Posted: October 23, 2020
• Study Start: October 30, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

NL (1)