Status:
RECRUITING
Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Phenogen Sciences
Conditions:
Genetic Testing
BRCA1/2
Eligibility:
FEMALE
25+ years
Brief Summary
The purpose of this study is to describe how women with BRCA1/2 mutations react to genetic risk modifier testing, and to examine how they make decisions about their healthcare.
Eligibility Criteria
Inclusion
- Female patient, age 25 years or older (given that women under this age are not generally recommended to receive BRCA1/2 genetic testing)
- Completed full sequence or targeted genetic testing with a clinically confirmed BRCA1 or BRCA2 deleterious mutation identified
- No personal history of breast cancer
- English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
Exclusion
- Previous receipt of any prophylactic mastectomy.
- Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
- Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03396341
Start Date
January 4 2018
End Date
January 1 2026
Last Update
February 7 2025
Active Locations (7)
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1
Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, United States, 02115
2
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
4
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604