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Clinical Trials/NCT02963688
NCT02963688
Completed
Not Applicable

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 sites298 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
To Investigate the Prevalence of BRCA 1/2 Mutation Among Ovarian Cancer
Sponsor
Samsung Medical Center
Enrollment
298
Primary Endpoint
Frequency of positive mutation among ovarian cancer patients
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2015
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Frequency of positive mutation among ovarian cancer patients

Time Frame: 5 year

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