IRB Study Number 24-446
Status Recruiting
Institute Taussig Cancer Institute
Description
2.1 Primary Objective
• To characterize the vaginal microbiome and change in female patients undergoing allogeneic HCT.
• To describe the incidence of vulvovaginal GVHD in this cohort
2.2 Secondary Objective(s)
• To explore the changes in vaginal microbiome in patients who develop chronic GVHD of the vaginal tract and compare to those who do not develop chronic GVHD.
Inclusion Criteria
• Female patients planning to undergo allogeneic HCT for any disease indication, OR, female patients 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.
• Age 18-70
• English speaking and able to sign written informed consent.
• Patients agree to a vaginal gynecologic exam.
• Co-enrollment on other clinical trials will be allowed.
Exclusion Criteria
• Patients 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 patient may not be able to comply with study assessments.
• Patients 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
• Patients with a history of lichen sclerosis, lichen planus, pre-transplant.
• Patients with a history or current diagnosis of vaginal or vulvar malignancy.
