Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
NCT ID: NCT03396341
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2018-01-04
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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patients receiving a positive BRCA1/2 mutation result
All interested participants will provide a saliva sample for genetic risk modifier testing, and will complete Assessment #1 questionnaires. Participants will be contacted 1 week later (+/- 1 week) to complete Assessment #2 questionnaires. Participants will be contacted 6 months (+/- 3 weeks) following the receipt of their genetic risk modifier results to complete Assessment #3 questionnaires. Participants will be encouraged to complete Assessments #2 and #3 via email using the secure, approved REDCap system
Salvia sample
salvia sample
Questionnaires
Participants will complete Assessment #1 questionnaires. Participants will be contacted 1 week later (+/- 1 week) to complete Assessment #2 questionnaires. Participants will be contacted 6 months (+/- 3 weeks) following the receipt of their genetic risk modifier results to complete Assessment #3 questionnaires. Participants will be encouraged to complete Assessments #2 and #3 via email using the secure, approved REDCap system
Interventions
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Salvia sample
salvia sample
Questionnaires
Participants will complete Assessment #1 questionnaires. Participants will be contacted 1 week later (+/- 1 week) to complete Assessment #2 questionnaires. Participants will be contacted 6 months (+/- 3 weeks) following the receipt of their genetic risk modifier results to complete Assessment #3 questionnaires. Participants will be encouraged to complete Assessments #2 and #3 via email using the secure, approved REDCap system
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
25 Years
FEMALE
No
Sponsors
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Phenogen Sciences
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jada Hamilton, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Dana Farber Cancer Institute (Data Collection Only)
Boston, Massachusetts, United States
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Abramson Cancer Center at University of Pennsylvania Medical Center (Data Collection Only)
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Mark Robson, MD
Role: CONTACT
Facility Contacts
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Judy Garber, MD, MPH
Role: primary
Jada Hamilton, PhD, MPH
Role: primary
Jada Hamilton, PhD, MPH
Role: primary
Jada Hamilton, PhD, MPH
Role: primary
Jada Hamilton, PhD, MPH
Role: primary
Mark Robson, MD
Role: backup
Jade Hamilton, PhD, MPH
Role: primary
Susan Domchek, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-489
Identifier Type: -
Identifier Source: org_study_id
NCT04943250
Identifier Type: -
Identifier Source: nct_alias
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