NCT06649201 Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation
| NCT ID | NCT06649201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Graft Vs Host Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-12-19 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Betty K Hamilton, MD
PRINCIPAL INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06649201 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Graft Vs Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649201 currently recruiting?
Yes, NCT06649201 is actively recruiting participants. Contact the research team at TaussigResearch@ccf.org for enrollment information.
Where is the NCT06649201 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06649201 clinical trial?
NCT06649201 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Betty K Hamilton, MD at Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center. The trial plans to enroll 40 participants.