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

ConditionsGraft Vs Host DiseaseVulvovaginal Signs and Symptoms
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

This trial does not accept healthy volunteers

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 population

Female participants undergoing allogenic HCT will be recruited from the Blood and Marrow Transplant Program at the Cleveland Clinic.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Vulvovaginal Symptom Questionnaire

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Allogeneic HCT participants2 interventions

Trial outcomes

Primary outcomes

1

Characterize the vaginal microbiome profile of female participants undergoing allogeneic HCT

A primary objective of this study is to characterize the vaginal microbiome and in female participants undergoing allogeneic HCT.

Time frame
Up to twelve months post-transplant
2

Characterize the change in vaginal microbiome profile of female participants undergoing allogeneic HCT

A primary objective of this study is to characterize the vaginal microbiome change in female participants undergoing allogeneic HCT.

Time frame
Up to twelve months post-transplant
3

Incidence of vulvovaginal GVHD

A primary objective is to measure the incidence of vulvovaginal GVHD in this cohort.

Time frame
Up to twelve months post-transplant

Secondary outcomes

1

Characterize the differences in vaginal microbiome between participants who develop vulvovaginal GVHS versus those who do not

The secondary objective is to investigate differences in vaginal microbiome between participants who develop vulvovaginal GVHD and those who do not.

Time frame
Up to twelve months post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Comprehensive Cancer Center

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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