Vulvovaginal Graft Versus Host Disease (VV-GVHD) in Women Who Underwent Transplantation Before and After Menarche
Recruitment status was Recruiting
The study will evaluate the prevalence and characteristics of vulvovaginal graft versus host disease (VV- GVHD) in patients who underwent hematopoietic stem cell transplantation (HSCT) as girls or adolescents and will compare the prevalence, characteristics and severity of VV-GVHD before and after menarche.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Vulvovaginal Graft Versus Host Disease in Women Who Underwent Transplantation Before and After Menarche|
- incidence of VV- GVHD in patients who underwent HSCT as girls or adolescents. [ Time Frame: 1 day ] [ Designated as safety issue: No ]Patients who underwent HSCT before the age of 18, who are 18 years or older at the time of the study, will be invited for a single appointment evaluation. Time from HSCT will range according to the date of transplantation, varying between 1-30 years.
- Prevalence, characteristics and severity of VV-GVHD before and after menarche [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Effect of sexual intercourse and/or virginity on the clinical manifestations of VV-GVHD in girls and adolescents. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Sexual development and maturity in regard to genital anatomy and the presence of VV-GVHD. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||February 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Patients who underwent allogeneic HSCT
Patients who underwent allogeneic HSCT before the age of 18, who are 18 years or older at the time of the study and who are alive.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01512498
|Contact: Ahinoam Lev-Sagie, MDfirstname.lastname@example.org|
|Contact: Michael Y Shapira, Prof.||+email@example.com|
|Hadassah University Hospital||Recruiting|
|Jerusalem, Israel, 91240|
|Contact: Ahinoam Lev Sagie, MD|
|Contact: Michael Shapira, MD|
|Principal Investigator:||Ahinoam Lev-Sagie, MD||Hadassah University Hospital, Jerusalem, ISRAEL|