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

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Samsung Medical Center

Status

Completed

Conditions

To Investigate the Prevalence of BRCA 1/2 Mutation Among Ovarian Cancer

Treatments

Genetic: Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02963688
SMC 2015-05-064

Details and patient eligibility

About

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.

Enrollment

298 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

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

Trial design

298 participants in 1 patient group

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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