Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy
Viome
Summary
30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.
Description
30 patients diagnosed with advanced or recurrent gynecological cancer who plan to receive immunotherapy treatment with a checkpoint inhibitor at AHMG AdventHealth Orlando Gynecological Oncology Group are recruited. Patients will be recruited 1-2 weeks prior to the beginning of treatment and appropriate informed consent will be obtained. Fecal samples; blood; saliva and vaginal swab samples will be collected among participants prior to their first treatment, after four doses of immunotherapy, and again at the completion of immunotherapy (follow-up). These 4 biomarker samples will undergo metatr…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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
Location
- AdventHealth Cancer InstituteOrlando, Florida