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NCT06649201 · ClinicalTrials.gov registry record
Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation
A clinical trial of Graft Vs Host Disease and Vulvovaginal Signs and Symptoms, sponsored by Case Comprehensive Cancer Center.
- Recruiting
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT06649201 is a study of Graft Vs Host Disease and Vulvovaginal Signs and Symptoms that is actively recruiting participants, run by Case Comprehensive Cancer Center. The registered enrollment target is 40 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06649201, a study of Graft Vs Host Disease and Vulvovaginal Signs and Symptoms, is actively recruiting participants, sponsored by Case Comprehensive Cancer Center.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Vulvovaginal Symptom Questionnaire
- DIAGNOSTIC_TEST Vaginal Microbiome Evaluation
Study Locations (1)
Ohio
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2027-02-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06649201
The ClinicalTrials.gov registry entry for NCT06649201 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (71% lower). The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Graft Vs Host Disease appearing as the primary indexed condition, and to 2 interventions - of which Vulvovaginal Symptom Questionnaire is the first listed.
NCT06649201 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06649201 about?
NCT06649201 is a clinical study titled "Vulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation". 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 c...
What is the current status of trial NCT06649201?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2024-12-19. Estimated completion is 2027-02-15.
What conditions does trial NCT06649201 study?
This clinical trial studies the following conditions: Graft Vs Host Disease, Vulvovaginal Signs and Symptoms.
What interventions are being tested in trial NCT06649201?
The interventions under investigation include: Vulvovaginal Symptom Questionnaire (OTHER), Vaginal Microbiome Evaluation (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06649201?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06649201 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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