RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-01
Study Completion:2027-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06649201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * All conditioning regimens (myeloablative or reduced intensity) will be included.
  3. * All donor sources (HLA matched/mismatched related, unrelated, umbilical cord, haploidentical) will be included.
  4. * All graft sources (bone marrow or peripheral blood stem cells) will be included.
  5. * All GVHD prophylaxis regimens will be included.
  6. * Aged 18-70.
  7. * English speaking and able to sign written informed consent.
  8. * Participants agree to a vaginal gynecologic exam.
  9. * Co-enrollment on other clinical trials will be allowed.
  1. * Participants who decline or unable to undergo vaginal gynecologic exam due to any discomfort or pain.
  2. * Any concurrent medical, psychiatric or other illness in which the provider believes the participants may not be able to comply with study assessments.
  3. * 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.
  4. * Participants with a history of lichen sclerosis, lichen planus, pre-transplant.
  5. * Participants with a history or current diagnosis of vaginal or vulvar malignancy.

Contacts and Locations

Study Contact

Betty K Hamilton, MD
CONTACT
1-866-223-8100
TaussigResearch@ccf.org

Principal Investigator

Betty K Hamilton, MD
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Betty K Hamilton, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2027-02-15

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2027-02-15

Terms related to this study

Keywords Provided by Researchers

  • Allogeneic Hematopoietic Cell Transplantation
  • Vaginal Microbiome
  • GVHD
  • HCT
  • Vulvovaginal GVHD
  • Vulvovaginal graft-versus-host disease

Additional Relevant MeSH Terms

  • Graft Vs Host Disease
  • Vulvovaginal Signs and Symptoms