Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649201
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Vulvovaginal Graft-versus-Host Disease Diagnosis and Microbiome Evaluation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Vulvovaginal Graft-versus-Host Disease Diagnosis and Microbiome Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Recent advances in technologies including high throughput metagenomic 16S rRNA gene sequencing have revealed a larger more complex picture of the bacterial diversity in the genital tract and unique microbial communities not previously recognized among the known vaginal flora categories Little is known about how the vaginal microbiome protects the female genital tract or other roles it may have including interacting with the microbiota of other body sites and subsequent inflammatory responses Alteration of vaginal flora may play a part in the pathogenesis of diseases by modulating immunity or increasing the growth of pathogenic strains Recent research has been conducted regarding changes in the vaginal microbiome during various infectious and inflammatory states such as bacterial vaginosis pelvic inflammatory disease sexually transmitted infectious and pregnancy However the vaginal microbiome during allogeneic HCT and development of genital GVHD has yet to be examined Thus the role of the vaginal microbiome in the development of genital GVHD is a critical area of study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None