Status:
COMPLETED
Counseling Interventions for BRCA 1/2 Cancer Susceptibility Testing
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
Breast Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
To evaluate two different ways of providing information about genetic testing for BRCA1 and BRCA2 alterations. The two forms of counseling are genetic counseling and enhanced informed consent which co...
Detailed Description
* Patients will have a blood sample drawn that will be analyzed for altered BRCA1 or BRCA2 genes. An alteration of BRCA1 or BRCA2 gene means there is an increased risk of developing breast and ovarian...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Member of a family in which a BRCA1 or BRCA2 deleterious germline mutation has been identified, whether or not the individual has had cancer herself; written documentation of the family mutation must be available for laboratory purposes during the testing process.
- Personal and/or family history of breast/ovarian/other cancer consistent with BRCA 1/2 heredity with posterior probability of carrying an altered gene
- Documentation of key family member cancer diagnoses is required
Exclusion
- Males, will be offered BRCA 1/2 testing through other protocols
- Individuals unable to speak or write English
- Already participated in a genetic counseling program for BRCA1 or BRCA2 testing
- Life expectancy of less than 12 months.
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00165152
Start Date
July 1 1998
End Date
June 1 2005
Last Update
August 9 2012
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115