An observational study in Gynecologic Cancer, Immunotherapy and Gut Microbiome, sponsored by Viome. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Viome · Observational
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.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 30 is below the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Viome is the lead sponsor of 25 studies on the registry; 13 are open to participants now.
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Advanced or recurrent gynecological cancer patients receiving immunotherapy from AHMG Advent Health Orlando Gynecologic Oncology Group
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Exclusion Criteria:
Taking medications that may affect gut microbiome:
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 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2021 (actual). Primary completion is estimated for Jun 2026, 60 months after the start.
Of 92 industry-sponsored observational studies under Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 102. This study's planned 60 months is above that.
Counting every sponsor, half of 884 studies reached it within 80 months; a quarter within 32 and three quarters within 318.
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