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Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
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.
Conditions:
🦠 Genetic Testing 🦠 BRCA1/2
🗓️ Study Start (Actual) 4 January 2018
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) January 2025
👥 Enrollment (Estimated) 350
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States
📍 Basking Ridge, New Jersey, United States
📍 Commack, New York, United States
📍 Harrison, New York, United States
📍 New York, New York, United States
📍 Uniondale, New York, United States
📍 Philadelphia, Pennsylvania, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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.
Ages Eligible for Study: 25 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 January 2018
  • First Submitted that Met QC Criteria 5 January 2018
  • First Posted 10 January 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024
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