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临床试验/NCT02963688
NCT02963688已完成不适用

Prevalence Study of Germline and/or Somatic BRCA1/2 Mutation in Korean Patients With High-Grade Serous and/or Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Samsung Medical Center0 个研究点目标入组 298 人开始时间: 2010年1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
298
主要终点
Frequency of positive mutation among ovarian cancer patients

研究概览

简要总结

PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2 mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial ovarian cancer (EOC).

PATIENTS AND METHODS: In a nationwide case-control study on EOC conducted in Korea between 2010 and 2015, 298 Korean women with HG serous and/or endometrioid EOC were tested for gBRCA 1/2 mutation, regardless of the family history. Mutation screening was performed using the Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) and Ion PGM platform according to the manufacturer's instructions. Clinical characteristics including survival outcome was assessed in gBRCAm carriers.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women 18 years of age and older with previously untreated, HG serous and/or endometrioid EOC, fallopian tube or primary peritoneal carcinoma who consented to genetic testing between 2010 and 2015

排除标准

  • women with mucinous , clear cell, low-grade serous or endometrioid, mixed epithelial adenocarcinoma, undiffereniated carcinoma or malignant brenner's tumor

结局指标

主要结局

Frequency of positive mutation among ovarian cancer patients

时间窗: 5 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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