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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Vulvovaginal Graft Versus Host Disease in Women Who Underwent Transplantation Before and After Menarche

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.

Detailed Summary:

The phenomenon of vulvovaginal graft versus host disease (VV-GVHD) following hematopoietic stem cell transplantation (HSCT) was first described in 1982 [Corson]. It is characterized by vulvovaginal inflammation, scarring, adhesions and might end with complete vaginal obliteration. Hematopoietic stem cells source for the allogeneic transplantation was found to affect the incidence of VV-GVHD: peripheral blood progenitor cells were associated with an incidence of 50% [Zantomio], while bone-marrow harvested cells were associated with an incidence of 25% [Spinelli].

Due to the high incidence of genital GVHD and its severe consequences we established a clinic designated for post- transplantation patients at the Hadassah University Hospital in Jerusalem. In a two years follow-up we found an incidence of 54% vulvovaginal GVHD in adult patients who attended the clinic, similar to the incidence described in the literature.

The data on VV-GVHD in the literature refers mainly to adult women. As gynecological examination and follow-up is not done routinely in girls and adolescents who are not sexually active, the incidence and characteristics of VV-GVHD in girls and adolescents who underwent HSCT is unknown.

Methods:

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 will be invited to participate in the study. Those who will be willing to participate will complete questionnaires and undergo physical and gynecological examination. At a single appointment, data will be acquired regarding: age, time from transplantation, current medical status, medications,hormonal status,marital status, sexual function and fertility (pregnancies and deliveries), assessment of
Sponsor: Hadassah Medical Organization

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Hadassah Medical Organization

Dates:
Date Received: January 11, 2012
Date Started: December 2012
Date Completion: February 2018
Last Updated: February 22, 2017
Last Verified: February 2017