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临床试验/NCT04757727
NCT04757727已完成不适用

Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Descriptve evaluation of the recruited population

研究概览

简要总结

Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • 18 years old or older
  • with hereditary dystrophic epidermolysis bullosa (dominant or recessive)
  • followed at the Nice University Hospital or at the St Louis Hospital of the APHP.
  • not opposed to participation after being informed of the study

排除标准

  • age < 18years old

结局指标

主要结局

Descriptve evaluation of the recruited population

时间窗: 12 months

Adult women (\> 18 years old) with hereditary dystrophic epidermolysis bullosa (dominant or recessive) followed at the Nice University Hospital or at the St Louis Hospital of the APHP. Descriptve evaluation of the recruited population Description of the anatomical and gynecological functional impairment of adult women with dystrophic epidermolysis bullosa.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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