NCT04600180Active, not recruitingNot Applicable
Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE
University Medical Center Groningen1 site in 1 country38 target enrollmentStarted: October 30, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- CD8+ T cell count in the gut mucosa
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
CD8+ T cell count in the gut mucosa
Time Frame: 8 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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