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

Description

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

Graft Vs Host Disease, Vulvovaginal Signs and Symptoms

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Graft Vs Host Disease
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

Betty K Hamilton, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Record Dates

2027-02-15