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

NCT01512498 | Completed

• 1 other identifier: MYS-09-HMO-CTIL
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Graft-vs-Host Disease

Keywords

VV GVHD; girls; adolescents; HSCT

Outcome Measures

Primary Outcomes (1)

• incidence of VV- GVHD in patients who underwent HSCT as girls or adolescents.

  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.

  1 day

Secondary Outcomes (3)

• Prevalence, characteristics and severity of VV-GVHD before and after menarche

  1 day

• Effect of sexual intercourse and/or virginity on the clinical manifestations of VV-GVHD in girls and adolescents.

  1 day

• Sexual development and maturity in regard to genital anatomy and the presence of VV-GVHD.

  1 day

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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 .

You may not qualify if:

• not able to comply with the study

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (2)

Pediatric Hematology Oncology Department, Rambam Hospital

Haifa, Israel

Location

Hadassah University Hospital

Jerusalem, 91240, Israel

Location

Related Publications (3)

• Zantomio D, Grigg AP, MacGregor L, Panek-Hudson Y, Szer J, Ayton R. Female genital tract graft-versus-host disease: incidence, risk factors and recommendations for management. Bone Marrow Transplant. 2006 Oct;38(8):567-72. doi: 10.1038/sj.bmt.1705487. Epub 2006 Sep 4.

  PMID: 16953208 BACKGROUND

• Spinelli S, Chiodi S, Costantini S, Van Lint MT, Raiola AM, Ravera GB, Bacigalupo A. Female genital tract graft-versus-host disease following allogeneic bone marrow transplantation. Haematologica. 2003 Oct;88(10):1163-8.

  PMID: 14555313 BACKGROUND

• Corson SL, Sullivan K, Batzer F, August C, Storb R, Thomas ED. Gynecologic manifestations of chronic graft-versus-host disease. Obstet Gynecol. 1982 Oct;60(4):488-92.

  PMID: 6750475 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Ahinoam Lev-Sagie, MD

  Hadassah University Hospital, Jerusalem, ISRAEL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician, the clinic for vulvovaginal disorders, Hadassah Mt Scopus

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 19, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)