What this study is
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.
What's being tested
- Vulvovaginal Symptom Questionnaire
Intervention · OTHER
Participants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant.
- Vaginal Microbiome Evaluation
Intervention · DIAGNOSTIC TEST
A vaginal microbiome evaluation will be performed via vaginal exam by a gynecologist with collection of vaginal samples once pre-transplant, six months, and twelve months post-transplant.
Study details
- Sponsor
- Case Comprehensive Cancer Center
- Conditions
- Graft Vs Host Disease · Vulvovaginal Signs and Symptoms
- Enrolling
- 40 people
- Starts
- 2024-12-19
- Est. completion
- 2027-02-15
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
- Betty, MD · Contact866-223-8100TaussigResearch@ccf.org
- Betty K Hamilton, MD · Principal investigator
Recruiting
Study team
Sponsor
Case Comprehensive Cancer Center
Study ID CASE2Z24
Principal investigator
Betty K Hamilton, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.