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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorCase Comprehensive Cancer Center

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vulvovaginal Symptom Questionnaire
  • Vaginal Microbiome Evaluation

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Case Comprehensive Cancer Center

Lead sponsor

Incyte Corporation

Collaborator