The Gut Immune System During Immune Checkpoint Inhibitor Therapy

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Oct 19, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system in the gut behaves before and after patients receive a type of cancer treatment called immunotherapy. Specifically, the researchers want to understand how certain immune cells change during treatment. If you participate, you will undergo a procedure called sigmoidoscopy, where doctors will take a small look inside your lower intestine and collect tiny samples of tissue. They will also take blood samples to check for signs of inflammation.

To be eligible for this study, you need to be an adult aged 65 or older and have been prescribed a specific type of immunotherapy known as anti-PD1/PDL1. You should also be able to provide written consent to participate. However, if you have had certain health issues in the past six months, especially related to your intestines, or if you've undergone specific treatments that could affect your gut health, you may not qualify for this trial. Overall, the study is open to all genders, and participants can expect to contribute to important research that may help improve cancer treatments in the future.

Gender

ALL

Eligibility criteria

• 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