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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: TaussigResearch@ccf.org
• Phone: 1-866-223-8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.