RECRUITING

Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-29
Study Completion:2024-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04957511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult females \> 18 years old
  2. * Advanced or recurrent gynecological cancer patients from AHMG Advent Health Orlando Gynecologic Oncology Group
  3. * Patients for whom an immunotherapy regimen has been ordered
  1. * Patients unable to provide fecal specimens at three time points
  2. * Patients unable to read or understand informed consent
  3. * Taking medications that may affect gut microbiome:
  4. * Proton pump inhibitors (PPIs)
  5. * Metformin
  6. * Antibiotics
  7. * Laxatives
  8. * Patients who are receiving investigational agent

Contacts and Locations

Study Contact

Momchilo Vuyisich, PhD
CONTACT
855 958 4663
studies@viome.com
Ryan Toma, MS
CONTACT

Principal Investigator

Momchilo Vuyisich, PhD
PRINCIPAL_INVESTIGATOR
Viome Life Sciences

Study Locations (Sites)

AdventHealth Cancer Institute
Orlando, Florida, 32804
United States

Collaborators and Investigators

Sponsor: Viome

  • Momchilo Vuyisich, PhD, PRINCIPAL_INVESTIGATOR, Viome Life Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-29
Study Completion Date2024-06

Study Record Updates

Study Start Date2021-06-29
Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Gynecologic Cancer
  • Immunotherapy
  • Gut Microbiome