Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation
- Graft Vs Host Disease
- Vulvovaginal Signs and Symptoms
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Case Comprehensive Cancer Center
- Enrolment target
- 40
- Started
- 19 December 2024
- Main results due
- November 2026
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 18 years to 70 years.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06649201. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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