Exploring the gut microbiome in gynecological cancer patients receiving immunotherapy
Official title: Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy
Run by Viome · NCT04957511 · Data updated 2026-11-12
This study is trying to see how the gut bacteria of women with advanced gynecological cancer affects their response to immunotherapy treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Viome Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Orlando, Florida) |
| Status | Recruiting |
| Started | June 29, 2021 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | January 29, 2025 |
| Trial ID | NCT04957511 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult females over 18 years old with advanced or recurrent gynecological cancer who are scheduled to receive immunotherapy.
✕Probably not a fit
Patients unable to provide the required biological samples or those on medications that significantly affect the gut microbiome may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study involves 30 participants with advanced or recurrent gynecological cancer who are set to receive immunotherapy. Participants will provide various biological samples, including fecal, blood, and swabs, before and during their treatment. The study aims to analyze these samples using metatranscriptomic methods to understand the gut microbiome's role in antitumor immunity and its interaction with immunotherapy. The findings will help inform future studies on the gut microbiome's impact on treatment outcomes.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies that enhance the effectiveness of immunotherapy in gynecological cancer patients.
How similar studies have gone: While studies on the gut microbiome's impact on cancer treatment are emerging, this specific approach is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult females \> 18 years old * Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group * Patients for whom an immunotherapy regimen has been ordered Exclusion Criteria: * Patients unable to provide fecal specimens at three time points * Patients unable to read or understand informed consent * Taking medications that may affect gut microbiome: * Proton pump inhibitors (PPIs) * Metformin * Antibiotics * Laxatives * Patients who are receiving investigational agent
Where it's running
-
AdventHealth Cancer Institute
Orlando, Florida, United States Recruiting
Study contacts
- Principal investigator: Momchilo Vuyisich, PhD — Viome Life Sciences
- Study coordinator: Momchilo Vuyisich, PhD
- Email: studies@viome.com
- Phone: 855 958 4663
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.