Cancer
Conditions
Keywords
Immune Checkpoint Inhibitor, Cancer, Gut Wall
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.
Interventions
PROCEDUREsigmoidoscopies 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.
Sponsors
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CD8+ T cell count in the gut mucosa | 8 weeks |
Countries
Netherlands
Outcome results
None listed