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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 298
- Primary Endpoint
- Frequency of positive mutation among ovarian cancer patients
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported