Actively Recruiting
Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation
Led by Case Comprehensive Cancer Center · Updated on 2026-03-09
40
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
C
Case Comprehensive Cancer Center
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants planning to undergo allogeneic HCT or who have developed vulvovaginal GVHD after HCT
- Any conditioning regimen including myeloablative or reduced intensity
- Any donor source including matched, mismatched, unrelated, umbilical cord, or haploidentical
- Any graft source including bone marrow or peripheral blood stem cells
- Any GVHD prevention regimen
- Age between 18 and 70 years
- English speaking and able to provide written informed consent
- Agree to vaginal gynecologic exams
- Co-enrollment in other clinical trials allowed
You will not qualify if you...
- Unable or unwilling to undergo vaginal gynecologic exam due to discomfort or pain
- Medical, psychiatric, or other illnesses that may prevent compliance with study assessments
- Current diagnosis or history of untreated sexually transmitted infections such as Herpes Simplex Virus, Gonorrhea, Chlamydia, or Trichomonas
- History of lichen sclerosis or lichen planus before transplant
- History or current diagnosis of vaginal or vulvar cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
B
Betty K Hamilton, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here