RecruitingNCT06649201

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


Sponsor

Case Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Dec 19, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Vaginal Microbiome Evaluation and Vulvovaginal Symptom Questionnaire for people with graft vs host disease and vulvovaginal signs and symptoms. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERVulvovaginal Symptom Questionnaire

Participants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant.

DIAGNOSTIC_TESTVaginal Microbiome Evaluation

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.


Locations(1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT06649201


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