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NCT Number: NCT05316740

Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hadassah Medical Center

Jerusalem, 9765422, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient does not approve sample collection

Treatment and study plan

No intervention

Other

Repeated clinical evaluation and sample collection

Primary outcomes

  1. Microbiome composition

    Time frame: 2 years

    Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing

  2. CMV presence

    Time frame: 2 years

    Evaluation of CMV in vaginal samples using PCR assay

  3. Vulvovaginal graft vs host disease presence

    Time frame: 2 years

    Evaluation of presence of vulvovaginal GVHD by gynecologic examination, using the NIH classification system for chronic graft-versus-host disease

Secondary outcomes

  1. HPV presence

    Time frame: 2 years

    Evaluation of HPV in vaginal samples

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Rambam Health Care Campus
  • Tel-Aviv Sourasky Medical Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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