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NCT04600180 Clinical Trial

The Gut Immune System During Immune Checkpoint Inhibitor Therapy

Cancer Clinical Trial

— DEFENCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04600180
Other study ID # 202000666
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 30, 2021
Est. completion date June 2024

Study information
Verified date May 2024
Source University Medical Center Groningen
Contact Jacco J. de Haan, MD, PhD
Phone +31 50 361 61 61
Email j.j.de.haan@umcg.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 38
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary CD8+ T cell count in the gut mucosa 8 weeks
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