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临床试验/NCT01512498
NCT01512498已完成不适用

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

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
incidence of VV- GVHD in patients who underwent HSCT as girls or adolescents.

研究概览

简要总结

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.

详细描述

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 sexual development by a pediatric endocrinologist regarding Tunner stages,data regarding possible vulvovaginal involvement, presence and scoring of GVHD in other organs and assessment of patients' well being using the FACT-BMT score.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • not able to comply with the study

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Sexual development and maturity in regard to genital anatomy and the presence of VV-GVHD.(1 day)
  • Effect of sexual intercourse and/or virginity on the clinical manifestations of VV-GVHD in girls and adolescents.(1 day)
  • Prevalence, characteristics and severity of VV-GVHD before and after menarche(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahinoam Lev-Sagie

Senior physician, the clinic for vulvovaginal disorders, Hadassah Mt Scopus

Hadassah Medical Organization

研究点 (2)

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