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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963688
• Other study ID #: SMC 2015-05-064
• Status: Completed
• Phase: N/A
• First received: November 8, 2016
• Last updated: November 14, 2016
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Genetic:
• Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform
BRCA1,2 Germline /Somatic mutation test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of positive mutation among ovarian cancer patients		5 year	No