Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease

Vaginal Microbiome and the Risk of Vulvovaginal Graft Versus Host Disease Following Hematopoietic Stem Cell Transplantation

Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients.

The suggested study aims to evaluate a possible association between vaginal microorganisms (the "microbiome") to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD.

Study Overview

• Status: Recruiting
• Conditions: Bone Marrow Transplant Complications
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ahinoam Lev-Sagie, MD; Phone Number: 0544327178; Email: levsagie@netvision.net.il

Study Locations

• Israel
  • Jerusalem, Israel, 9765422
    • Recruiting
    • Hadassah Medical Center
    • Contact: Ahinoam Lev-Sagie, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Female patients planned for HSCT

Description

Inclusion Criteria:

• Age≥18
• Candidate for allogeneic stem cell transplantation
• Ability to sign an informed consent

Exclusion Criteria:

- Patient does not approve sample collection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiome composition	Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing	2 years
CMV presence	Evaluation of CMV in vaginal samples using PCR assay	2 years
Vulvovaginal graft vs host disease presence	Evaluation of presence of vulvovaginal GVHD by gynecologic examination, using the NIH classification system for chronic graft-versus-host disease	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV presence	Evaluation of HPV in vaginal samples	2 years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Rambam Health Care Campus; Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Ahinoam Lev Sagie, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 0512-21-HMO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No