RecruitingNCT04957511
Gut Microbiome and Treatment for 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
Sponsor
Viome
Enrollment
30 participants
Start Date
Jun 29, 2021
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria3
- 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 Criteria8
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04957511
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