Exploring the gut microbiome in gynecological cancer patients receiving immunotherapy
Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Viome Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT04957511 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult females over 18 years old with advanced or recurrent gynecological cancer who are scheduled to receive immunotherapy.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orlando, Florida
- 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
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.