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

This study is currently recruiting participants.
Verified February 2017 by Ahinoam Lev-Sagie, Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT01512498
First Posted: January 19, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Hadassah Medical Organization
  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
Graft-vs-Host Disease

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

Resource links provided by NLM:


Further study details as provided by Ahinoam Lev-Sagie, Hadassah Medical Organization:

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

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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


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
Pediatric Hematology Oncology Department, Rambam Hospital Recruiting
Haifa, Israel
Contact: Irina Zaidman, MD       i_zaidman@rambam.health.gov.il   
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
First Submitted: January 11, 2012
First Posted: January 19, 2012
Last Update Posted: February 23, 2017
Last Verified: February 2017
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:
Graft vs Host Disease
Immune System Diseases