Evaluating vulvovaginal graft-versus-host disease and the vaginal microbiome

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

This study is trying to see how changes in the vaginal bacteria of women who have a stem cell transplant might relate to the development of vulvovaginal graft-versus-host disease.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Case Comprehensive Cancer Center (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06649201 on ClinicalTrials.gov

What this trial studies

This observational study investigates vulvovaginal graft-versus-host disease (GVHD) in female participants undergoing allogeneic hematopoietic cell transplantation (HCT). It aims to characterize the vaginal microbiome before and after transplantation to understand its role in the development of vulvovaginal GVHD. Participants will complete a vulvovaginal symptom questionnaire and undergo vaginal microbiome evaluations at specified intervals. The study seeks to uncover how changes in the vaginal microbiome may correlate with the onset of GVHD.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18-70 who are planning to undergo or have undergone allogeneic HCT and may have developed vulvovaginal GVHD.

Not a fit: Patients who are unable or unwilling to undergo a vaginal gynecologic exam or who have significant concurrent medical or psychiatric conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of vulvovaginal GVHD, enhancing the quality of life for affected patients.

How similar studies have performed: While there has been research on the vaginal microbiome in various conditions, this specific focus on vulvovaginal GVHD during allogeneic HCT is novel and has not been extensively studied.

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.

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Betty K Hamilton, MD — Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
• Study coordinator: Betty K Hamilton, MD

Conditions: Graft Vs Host Disease, Vulvovaginal Signs and Symptoms, Allogeneic Hematopoietic Cell Transplantation, Vaginal Microbiome, GVHD, HCT, Vulvovaginal GVHD, Vulvovaginal graft-versus-host disease