Gut Microbiome and Immunotherapy for Gynecological Cancer

This observational study is looking at how the gut microbiome (the community of bacteria in your intestines) might be connected to how well immunotherapy works for women with advanced or recurrent gynecological cancer. Researchers will collect samples like stool, blood, vaginal swabs, and oral swabs from about 30 participants before, during, and after their immunotherapy treatment. By analyzing these samples, they hope to understand how changes in the gut microbiome relate to the effectiveness of checkpoint inhibitor immunotherapy. This information could help design future studies to improve treatment for gynecological cancer patients.

Study design
This is an observational study involving about 30 participants. It is not specified if it is randomized or blinded.
What's involved
You would provide fecal, blood, vaginal swab, and oral mucosal swab samples at three different times: before treatment, after four doses of immunotherapy, and at the end of immunotherapy. You would also complete a food dietary questionnaire.
Compensation
Not stated in the trial record.
Follow-up
Microbiome changes will be measured through analysis of biological samples over approximately two years.

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NCT04957511

Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

Recruiting
Not specifiedAges 18+Observational
Viome
~30 participants
Updated 2025-01-29 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab).
Measured over ~2 years
Gynecologic Cancer
Immunotherapy
Gut Microbiome
1 sites across 1 states
Florida1
  • Momchilo Vuyisich, PhD · PRINCIPAL_INVESTIGATOR · Viome Life Sciences

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Eligibility criteria

Inclusion

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

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
  • Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab).~2 years

    Changes are measured between the genetic microbiome signatures of advanced or recurrent gynecological cancer patients who are receiving immune checkpoint inhibitors.