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Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation

Who can join

Ages 18 to 70 · Women

Inclusion Criteria:

* Female participants planning to undergo allogeneic HCT for any disease indication, OR, female participants who have already received HCT and have developed vulvovaginal GVHD during their post-transplant follow-up period
* All conditioning regimens (myeloablative or reduced intensity) will be included.
* All donor sources (HLA matched/mismatched related, unrelated, umbilical cord, haploidentical) will be included.
* All graft sources (bone marrow or peripheral blood stem cells) will be included.
* All GVHD prophylaxis regimens will be included.
* Aged 18-70.
* English speaking and able to sign written informed consent.
* Participants agree to a vaginal gynecologic exam.
* Co-enrollment on other clinical trials will be allowed.

Exclusion Criteria:

* Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain.
* Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments.
* Participants with a current diagnosis of a sexually transmitted infection (STI) (Herpes Simplex Virus, Gonorrhea, Chlamydia, Trichomonas,) or a history of previously untreated STI which may incite inflammation that will impact the microbiome.
* Participants with a history of lichen sclerosis, lichen planus, pre-transplant.
* Participants with a history or current diagnosis of vaginal or vulvar malignancy.

About the study

The goal of this observational study is to investigate the development of vulvovaginal graft-versus-host- disease (GVHD), an under-reported and under-recognized manifestation of chronic GVHD. This study aims to characterize the vaginal microbiome in participants undergoing allogeneic hematopoietic cell transplantation (HCT). The main questions it aims to answer are:

* Is the vaginal microbiome altered during allogeneic HCT? * What changes may help researchers understand the development of vulvovaginal GVHD?

Participants will be asked to undergo an assessment of vulvovaginal symptoms through a vulvovaginal symptom questionnaire once pre-transplant, 6 months post-transplant, and twelve12 months post- transplant. Participants will also be asked to undergo a vaginal microbiome (collection of bacteria, fungi, and viruses that live on our bodies) evaluation through a vaginal exam performed by a gynecologist with collection of vaginal samples once pre-transplant and again six months post-treatment and twelve months post-transplant. If a participant develops symptoms of vulvovaginal GVHD at any point in time during the post-transplant follow up, the participant may partake in additional vaginal exams to diagnose GVHD at the time of symptom onset.

What is being tested

• Vulvovaginal Symptom Questionnaire (other)
• Vaginal Microbiome Evaluation (diagnostic test)

Sponsor: Case Comprehensive Cancer Center · Participants: 40 · Started: Dec 19, 2024

Contact the study team

• Betty K Hamilton, MD · Phone: 1-866-223-8100

Official record on ClinicalTrials.gov — NCT06649201

Locations in the U.S.

Conditions

• Graft-Versus-Host Disease

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.