Recruiting

Observational Study

Sponsor:

Viome

Code:

NCT04957511

Conditions

Gynecologic Cancer

Immunotherapy

Gut Microbiome

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04957511

Start date

Jun 29, 2021

Status verified date

Jan, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Microbiome change through analysis of biological samples (fecal specimen, blood, vaginal swab, oral mucosal swab). [ Time Frame: ~2 years ]

Central Contacts and Locations

Central contacts

Momchilo Vuyisich, PhD

855 958 4663studies@viome.com

Locations

AdventHealth Cancer Institute

Recruiting

Orlando, Florida, United States, 32804

Contacts

Jessica Chestnut

407 303 2451Jessica.Chestnut@adventhealth.com

Principal Investigator:

Nathalie McKenzie, MD

More Information

Sponsor

Viome

Last update posted

Jan 29, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Viome on 2025-01-29.