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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06649201
Status
Recruiting
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Conditions

  • Graft Vs Host Disease
  • Vulvovaginal Signs and Symptoms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Vulvovaginal Symptom Questionnaire — OTHER
    Participants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant.
  • Vaginal Microbiome Evaluation — DIAGNOSTIC_TEST
    A vaginal microbiome evaluation will be performed via vaginal exam by a gynecologist with collection of vaginal samples once pre-transplant, six months, and twelve months post-transplant.

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Feb 15, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Allogeneic HCT participants
    The cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic.

Primary Outcome Measure

Characterize the vaginal microbiome profile of female participants undergoing allogeneic HCT [ Time Frame: Up to twelve months post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195
Betty, MD
[email protected]
866-223-8100
Betty K Hamilton, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

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