RecruitingNCT04957511

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


Sponsor

Viome

Enrollment

30 participants

Start Date

Jun 29, 2021

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

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Locations(1)

AdventHealth Cancer Institute

Orlando, Florida, United States

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NCT04957511


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