The Gut Immune System During Immune Checkpoint Inhibitor Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-30

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Palliative treatment with immunotherapy

sigmoidoscopies and and venous blood sampling

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No