Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease

Bone Marrow Transplant Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316740
• Other study ID #: 0512-21-HMO
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Hadassah Medical Organization
• Contact: Ahinoam Lev-Sagie, MD
• Phone: 0544327178
• Email: levsagie[@]netvision.net.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age=18

• Candidate for allogeneic stem cell transplantation

• Ability to sign an informed consent

Exclusion Criteria:

• Patient does not approve sample collection

Related Conditions & MeSH terms

• Bone Marrow Transplant Complications
• Graft vs Host Disease

Intervention

Other:
• No intervention
Repeated clinical evaluation and sample collection

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (3)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Rambam Health Care Campus, Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome composition	Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing	2 years
Primary	CMV presence	Evaluation of CMV in vaginal samples using PCR assay	2 years
Primary	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	HPV presence	Evaluation of HPV in vaginal samples	2 years