Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease

NCT05316740 | Active Not Recruiting

• 1 other identifier: 0512-21-HMO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Marrow Transplant Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• HPV presence

  2 years

Interventions

No intervention OTHER

Repeated clinical evaluation and sample collection

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients planned for HSCT

You may qualify if:

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

You may not qualify if:

• \- Patient does not approve sample collection

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Rambam Health Care Campus: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (1)

Hadassah Medical Center

Jerusalem, Jerusalem, 9765422, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal samples will be collected for: 1. Microbiome molecular analysis: aimed to determine whether changes in the vaginal bacterial microbiome precede or follow VV-GVHD. 2. HPV presence. 3. CMV presence

Study Officials

• Ahinoam Lev Sagie, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 7, 2022
• Study Start: February 15, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

IL (1)