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临床试验/NCT04755803
NCT04755803已完成不适用

A Prospective Registry of Patients With Congenital Penile Anomalies

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年7月10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
32
试验地点
1
主要终点
Dartos Fascia (Penile Tissue) sample collection

研究概览

简要总结

Prospective registry and biobank in pediatric patients with congenital penile anomalies

详细描述

According to the U.S. Center for Disease Control and Prevention, in the United States, one in 200 babies is born with congenital penile anomalies. In Korea, there is a rapid increase rate among other types of congenital anomalies from 1993 to 2010, from 0.7 to 10,000 to 9.9 per 10,000 cases. It leaves long term sequelae into adulthood even after the corrective operation has been performed. Some of the sequelae that patients experienced were difficulties in micturition, dissatisfaction with the appearance of the penis, and decreased sexual function, as well as psychosexual well-being.

Despite its high prevalence, hypospadias and related penile anomalies have no specific known etiology and mechanisms. However, numerous studies have shown that both gene and environment play a significant role in making etiologies multifactorial. Furthermore, a molecular trial shows that both genetics and environmental factors disrupt the normal development course of the phallus, or penis. Penis formation, growth, or the formation of the male urogenital system, in general, have shown to be androgen dependent. Any defect in the androgen synthesis leading to androgen deficiency or receptors may play a role, specifically, in the development of penile anomalies.

Pediatric patients between the ages of 0 to 18 years, with congenital penile anomalies and scheduled to undergo penoplasty will be enrolled. In this prospective observational study, our aims are to collect dartos fascia, which is a tissue in penile region, and examine histochemistry of the sample.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Months 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Those with congenital penile anomalies (e.g. hypospadias, chordee, webbed penis) and receiving penoplasty at the institution.
  • Those who understand the registry's content and are signed and dated by the patient (or the patient's legal guardian or representative).

排除标准

  • Those who are unwilling to participate and do not sign the informed consent.
  • Unable to read or understand Korean.

结局指标

主要结局

Dartos Fascia (Penile Tissue) sample collection

时间窗: Procedure (At the time of penoplasty)

Collection of biological samples from pediatric patients who have been registered onto the prospective registry.

次要结局

未报告次要终点

研究者

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

Kwanjin Park

Principal Investigator

Seoul National University Hospital

研究点 (1)

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