Exploring the gut immune system during immunotherapy for cancer
Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE
This study is trying to see how cancer immunotherapy affects the immune system in the gut of patients by taking samples before and during their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Groningen) |
| Trial ID | NCT04600180 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the gut immune system's response to immune checkpoint inhibitor therapy in cancer patients. Participants will undergo sigmoidoscopies to collect biopsies from the sigmoid and rectum before and during treatment. These samples will be analyzed for immune cell phenotypes, while blood samples will be taken to monitor inflammatory markers. The goal is to understand how the gut immune system changes in response to immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are cancer patients who are indicated for treatment with anti PD1/PDL1 based immunotherapy.
Not a fit: Patients with recent gastrointestinal issues or those who have undergone certain surgeries or treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that enhance the effectiveness of immunotherapy in cancer treatment.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in understanding immune responses during cancer therapies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jacco J. de Haan, MD, PhD — University Medical Center Groningen
- Study coordinator: Jacco J. de Haan, MD, PhD
- Email: j.j.de.haan@umcg.nl
- Phone: +31 50 361 61 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.