BRCA 1/2 Mutation in Korean Patients With Epithelial Ovarian Cancer

Completed

• Conditions: To Investigate the Prevalence of BRCA 1/2 Mutation Among Ovarian Cancer
• Interventions: Genetic: Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform

• Registration Number: NCT02963688
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-14
• Last Update Submitted: 2016-11-14
• Study First Posted: 2016-11-15
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 298

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KGOG 3019	Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform	Korean women with HG serous and/or endometrioid epithelial ovarian cancer

Primary Outcome Measures

Name	Time	Method
Frequency of positive mutation among ovarian cancer patients	5 year