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

NCT06649201 | Recruiting DMC

• 1 other identifier: CASE2Z24
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Graft Vs Host Disease; Vulvovaginal Signs and Symptoms

Keywords

Allogeneic Hematopoietic Cell Transplantation; Vaginal Microbiome; GVHD; HCT; Vulvovaginal GVHD; Vulvovaginal graft-versus-host disease

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to twelve months post-transplant

• 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.

  Up to twelve months post-transplant

• Incidence of vulvovaginal GVHD

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

  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

  Up to twelve months post-transplant

Study Arms (1)

Allogeneic HCT participants

The cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic.

Other: Vulvovaginal Symptom Questionnaire; Diagnostic Test: Vaginal Microbiome Evaluation

Interventions

Vulvovaginal Symptom Questionnaire OTHER

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

Allogeneic HCT participants

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.

Allogeneic HCT participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Incyte Corporation: collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Microbiome samples will be collected by a provider and will be transported to the Genomic Medicine Biorepository Core laboratory. All samples will be de-identified, coded and stored in the Genomic Medicine Biorepository indefinitely using established practice of the Genomic Medicine Biorepository Core. Additional samples for gonorrhea, chlamydia, bacterial vaginosis, candidiasis and trichomoniasis will be transported to the general Cleveland Clinic Laboratory and processed there using their standard protocols per clinic standard of care.

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Betty K Hamilton, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betty K Hamilton, MD

CONTACT

1-866-223-8100; TaussigResearch@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: December 19, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)