Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

Pilot Feasibility Study of the Interplay Between the Host Gut Microbiome and Efficacy of Treatment for Advanced or Recurrent Gynecological Cancer Patients Receiving Immunotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Immunotherapy; Gut Microbiome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Momchilo Vuyisich, PhD; Phone Number: 855 958 4663; Email: studies@viome.com
• Study Contact Backup: Name: Ryan Toma, MS

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Cancer Institute
      • Contact: Robert Holloway, MD
      • Contact: Jessica Chestnut; Phone Number: 407 303 2451; Email: Jessica.Chestnut@adventhealth.com
      • Contact: Nathalie McKenzie, MD
      • Contact: James Kendrick, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Viome
• Collaborators: AdventHealth
• Investigators: Principal Investigator: Momchilo Vuyisich, PhD, Viome Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Microbiome; Nutrition; Diet; Gynecology; RNAseq; Gastrointestinal; ICI; Viome; Biome; Immune check point inhibitors; ICIs; Anti-tumor immunity
• Other Study ID Numbers: V235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No