Hadassah Medical Center
Jerusalem, 9765422, Israel
NCT Number: NCT05316740
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Observational
Jerusalem, 9765422, Israel
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Repeated clinical evaluation and sample collection
Time frame: 2 years
Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing
Time frame: 2 years
Evaluation of CMV in vaginal samples using PCR assay
Time frame: 2 years
Evaluation of presence of vulvovaginal GVHD by gynecologic examination, using the NIH classification system for chronic graft-versus-host disease
Time frame: 2 years
Evaluation of HPV in vaginal samples
Hadassah Medical Organization
Other
Vaginal Microbiome and the Risk of Vulvovaginal Graft Versus Host Disease Following Hematopoietic Stem Cell Transplantation
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