Recruiting

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT06649201

Conditions

Graft Vs Host Disease

Vulvovaginal Signs and Symptoms

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Vulvovaginal Symptom Questionnaire

Vaginal Microbiome Evaluation

Study Details

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.

Conditions

Graft Vs Host Disease

Vulvovaginal Signs and Symptoms

Study ID

NCT06649201

Start date

Dec 19, 2024

Status verified date

Aug, 2026

Completion date

Feb 15, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Allogeneic HCT participants

The cohort will be comprised of participants undergoing allogeneic HCT at the Cleveland Clinic.

Interventions

Vulvovaginal Symptom Questionnaire

Participants will undergo assessment of vulvovaginal symptoms via the vulvovaginal questionnaire once pre-transplant, six months, and develop months post-transplant.

Vaginal Microbiome Evaluation

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.

Primary outcome measure

  • Characterize the vaginal microbiome profile of female participants undergoing allogeneic HCT [ Time Frame: Up to twelve months post-transplant ]
  • Characterize the change in vaginal microbiome profile of female participants undergoing allogeneic HCT [ Time Frame: Up to twelve months post-transplant ]
  • Incidence of vulvovaginal GVHD [ Time Frame: Up to twelve months post-transplant ]

Central Contacts and Locations

Central contacts

Betty K Hamilton, MD

1-866-223-8100TaussigResearch@ccf.org

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Betty, MD

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Betty K Hamilton, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-26.