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Vulvovaginal Graft Versus Host Disease (VV-GVHD) in Women Who Underwent Transplantation Before and After Menarche

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ClinicalTrials.gov Identifier: NCT01512498
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Hadassah Medical Organization

Brief Summary:
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.

Condition or disease
Graft-vs-Host Disease

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vulvovaginal Graft Versus Host Disease in Women Who Underwent Transplantation Before and After Menarche
Study Start Date : December 2012
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. incidence of VV- GVHD in patients who underwent HSCT as girls or adolescents. [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Prevalence, characteristics and severity of VV-GVHD before and after menarche [ Time Frame: 1 day ]
  2. Effect of sexual intercourse and/or virginity on the clinical manifestations of VV-GVHD in girls and adolescents. [ Time Frame: 1 day ]
  3. Sexual development and maturity in regard to genital anatomy and the presence of VV-GVHD. [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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 .
Criteria

Inclusion criteria:

  • 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 willing to participate in the study .

Exclusion Criteria:

  • not able to comply with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512498


Locations
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Israel
Pediatric Hematology Oncology Department, Rambam Hospital
Haifa, Israel
Hadassah University Hospital
Jerusalem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Ahinoam Lev-Sagie, MD Hadassah University Hospital, Jerusalem, ISRAEL

Publications:
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Responsible Party: Ahinoam Lev-Sagie, Senior physician, the clinic for vulvovaginal disorders, Hadassah Mt Scopus, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01512498     History of Changes
Other Study ID Numbers: MYS-09-HMO-CTIL
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ahinoam Lev-Sagie, Hadassah Medical Organization:
VV GVHD
girls
adolescents
HSCT
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases