Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorViome
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients unable to provide fecal specimens at three time points
Patients unable to read or understand informed consent
Proton pump inhibitors (PPIs)
Metformin
Trial population
Advanced or recurrent gynecological cancer patients receiving immunotherapy from AHMG Advent Health Orlando Gynecologic Oncology Group
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab).
Changes are measured between the genetic microbiome signatures of advanced or recurrent gynecological cancer patients who are receiving immune checkpoint inhibitors.
Time frame
~2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Viome
Lead sponsor
AdventHealth
Collaborator
Source ClinicalTrials.gov