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

NCT ID: NCT06649201

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2027-02-15

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.

Detailed Description

Recent advances in technologies including high throughput metagenomic 16S rRNA gene sequencing have revealed a larger, more complex picture of the bacterial diversity in the genital tract and unique microbial communities not previously recognized among the known vaginal flora categories. Little is known about how the vaginal microbiome protects the female genital tract or other roles it may have, including interacting with the microbiota of other body sites and subsequent inflammatory responses. Alteration of vaginal flora may play a part in the pathogenesis of diseases by modulating immunity or increasing the growth of pathogenic strains. Recent research has been conducted regarding changes in the vaginal microbiome during various infectious and inflammatory states such as bacterial vaginosis, pelvic inflammatory disease, sexually transmitted infectious, and pregnancy. However, the vaginal microbiome during allogeneic HCT and development of genital GVHD has yet to be examined. Thus, the role of the vaginal microbiome in the development of genital GVHD is a critical area of study.

Conditions

Graft Vs Host Disease; Vulvovaginal Signs and Symptoms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Allogeneic HCT participants

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

Vulvovaginal Symptom Questionnaire

Intervention Type: OTHER

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

Vaginal Microbiome Evaluation

Intervention Type: 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.

Interventions

Vulvovaginal Symptom Questionnaire

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

Intervention Type: OTHER

Vaginal 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Betty K Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Betty K Hamilton, MD

Role: CONTACT

TaussigResearch@ccf.org

1-866-223-8100

Facility Contacts

Betty, MD

Role: primary

TaussigResearch@ccf.org

866-223-8100

Other Identifiers

CASE2Z24

Identifier Type: -

Identifier Source: org_study_id