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| Name | Class |
|---|---|
| AdventHealth | OTHER |
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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.
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 metatranscriptomic analysis, also known as RNAseq, method of sample analysis. Only RNA molecules are sequenced, while DNA is degraded. for bacterial community analysis. These findings will help to design a future study to examine the role of the gut microbiome in antitumor immunity and its effect on immune checkpoint inhibitor therapy for advanced or recurrent gynecological cancer. NHANES Food Frequency Questionnaire will be collected prior to participants' first treatments.
The short-term goals of this pilot study are to obtain preliminary data on the gut bacterial microbiome of patients with advanced or recurrent gynecological cancer. The long-term goals of this study is to begin to understand how the gut microbiome changes within an individual patient undergoing immunotherapy, to gut microbiome differs among patients undergoing immunotherapy, and to examine whether the gut microbiome is associated with the response to cancer immunotherapy.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | ~2 years |
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Inclusion Criteria:
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:
Patients who are receiving investigational agent
Adult females >18 years old
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Advanced or recurrent gynecological cancer patients receiving immunotherapy from AHMG Advent Health Orlando Gynecologic Oncology Group
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Momchilo Vuyisich, PhD | Contact | 855 958 4663 | studies@viome.com | |
| Ryan Toma, MS | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Momchilo Vuyisich, PhD | Viome Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Cancer Institute | Recruiting | Orlando | Florida | 32804 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Only RNA molecules are sequenced, while DNA is degraded. The AdventHealth Research Laboratory will process the de-identified blood samples and store; Plasma, Serum and Buffy Coat for future analysis. The Advent Health Research Laboratory will store these samples in the biorepository, inventory and chain of custody will be managed by the STARLIMS program.