The Gut Immune System During Immune Checkpoint Inhibitor Therapy
Recruiting
- Conditions
- Cancer
- Interventions
- Procedure: sigmoidoscopies and and venous blood sampling
- Registration Number
- NCT04600180
- Lead Sponsor
- University Medical Center Groningen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 38
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Palliative treatment with immunotherapy sigmoidoscopies and and venous blood sampling -
- Primary Outcome Measures
Name Time Method CD8+ T cell count in the gut mucosa 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands