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

Launched by CASE COMPREHENSIVE CANCER CENTER · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a condition called vulvovaginal graft-versus-host disease (GVHD), which can develop after a type of cancer treatment called allogeneic hematopoietic cell transplantation (HCT). The goal is to learn more about how this condition affects women and to understand the changes in the vaginal microbiome—the collection of bacteria, fungi, and viruses that naturally live in the vagina—during and after the treatment. The trial will involve female participants who are either planning to undergo HCT or have already had the procedure and are experiencing symptoms of vulvovaginal GVHD.

To participate, women aged 18 to 70 who can speak English and agree to a vaginal exam can enroll in the study. They will complete a questionnaire about their vulvovaginal symptoms before the transplant, and again 6 and 12 months later. Additionally, they will undergo vaginal exams and sample collections at these same times to evaluate changes in their vaginal microbiome. If a participant develops symptoms of vulvovaginal GVHD at any point, they may have further exams to help diagnose the condition. This study is important because it aims to improve our understanding of vulvovaginal GVHD, which is often overlooked, and could lead to better care for women undergoing HCT.

Gender

FEMALE

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.