Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600180
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2020-10-19
Brief Title:
The Gut Immune System During Immune Checkpoint Inhibitor Therapy
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEFENCE
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None