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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01512498
First received: January 11, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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 Phase
Graft-vs-Host Disease
Phase 1

Study Type: Observational
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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
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)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512498

Contacts
Contact: Ahinoam Lev-Sagie, MD +972-2-5844400 levsagie@netvision.net.il
Contact: Michael Y Shapira, Prof. +972-2-6778351 shapiram@hadassah.org.il

Locations
Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91240
Contact: Ahinoam Lev Sagie, MD         
Contact: Michael Shapira, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ahinoam Lev-Sagie, MD Hadassah University Hospital, Jerusalem, ISRAEL
  More Information

Publications:
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
Study First Received: January 11, 2012
Last Updated: December 13, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
VV GVHD
girls
adolescents
HSCT

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014