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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Indication for treatment with anti PD1/PDL1 based immunotherapy

• Written informed consent

• Evaluable according to iRECIST v1.1

Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Jacco J. de Haan, MD, PhD
j.j.de.haan@umcg.nl
+31 50 361 61 61
Backup
Wouter B. Nagengast, Prof.
w.b.nagengast@umcg.nl
+31 50 361 61 61
Time Frame
Start Date: 2021-10-30
Estimated Completion Date: 2025-06
Participants
Target number of participants: 38
Treatments
Palliative treatment with immunotherapy
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov