Trials / Active Not Recruiting
Active Not RecruitingNCT04600180
The Gut Immune System During Immune Checkpoint Inhibitor Therapy
Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 38 (estimated)
- Sponsor
- University Medical Center Groningen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-10-30
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2020-10-23
- Last updated
- 2025-11-25
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04600180. Inclusion in this directory is not an endorsement.