NCT04957511 Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
| NCT ID | NCT04957511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Viome |
| Condition | Gynecologic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-06-29 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2021-06-29 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Momchilo Vuyisich, PhD
PRINCIPAL INVESTIGATOR
Viome Life Sciences
Frequently Asked Questions
Who can join the NCT04957511 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04957511 currently recruiting?
Yes, NCT04957511 is actively recruiting participants. Contact the research team at studies@viome.com for enrollment information.
Where is the NCT04957511 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT04957511 clinical trial?
NCT04957511 is sponsored by Viome. The principal investigator is Momchilo Vuyisich, PhD at Viome Life Sciences. The trial plans to enroll 30 participants.
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