Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

NCT04957511 | Recruiting

• 1 other identifier: V235
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Immunotherapy; Gut Microbiome

Keywords

Biome; Microbiome; Gastrointestinal; Immune check point inhibitors; Nutrition; Diet; Viome; ICI; ICIs; RNAseq; Anti-tumor immunity; Cancer; Gynecology

Outcome Measures

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.

  ~2 years

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adult females \>18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced or recurrent gynecological cancer patients receiving immunotherapy from AHMG Advent Health Orlando Gynecologic Oncology Group

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viome: lead
• AdventHealth: collaborator

Study Sites (1)

AdventHealth Cancer Institute

Orlando, Florida, 32804, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Momchilo Vuyisich, PhD

  Viome Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Momchilo Vuyisich, PhD

CONTACT

855 958 4663; studies@viome.com

Ryan Toma, MS

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 12, 2021
• Study Start: June 29, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)