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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Betty K Hamilton, MD
TaussigResearch@ccf.org
1-866-223-8100
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2027-02-15
Participants
Target number of participants: 40
Treatments
Allogeneic HCT participants
The cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic.
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center
Collaborators: Incyte Corporation

This content was sourced from clinicaltrials.gov