Responses to Genetic Risk Modifier Testing Among Women With Pathogenic Variants in Breast Cancer Predisposition Genes

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03396341
Status
Recruiting
Apply to this trial

Conditions

  • BRCA1/2
  • Genetic Testing

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Salvia sample — OTHER
    salvia sample
  • Questionnaires — BEHAVIORAL
    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
  • Buccal swab sample — OTHER
    Buccal swab sample

Study Details

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.

Key Dates

Start date
Jan 4, 2018
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
806 participants (estimated)

Arms

  • Arm: Phase I: 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
  • Arm: Phase 2:
    Participants with a pathogenic/likely pathogenic variant in one of the following breast cancer predisposition genes: BRCA1, BRCA2, ATM, CHEK2, PALB2.

Primary Outcome Measure

Number of participants that opt for preventive mastectomy or to pursue surveillance [ Time Frame: 3 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer Institute (Data Collection Only)BostonMassachusetts02115
Judy Garber, MD, MPH
617-632-5961
Memorial Sloan-Kettering at Basking RidgeBasking RidgeNew Jersey07920
Jada Hamilton, PhD, MPH
646-888-0049
Memorial Sloan Kettering CommackCommackNew York11725
Jada Hamilton, PhD, MPH
646-888-0049
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Jada Hamilton, PhD, MPH
646-888-0049
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Jada Hamilton, PhD, MPH
646-888-0049
Mark Robson, MD
646-888-5486
Jada Hamilton, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering NassauUniondaleNew York11553
Jade Hamilton, PhD, MPH
646-888-0049
Abramson Cancer Center at University of Pennsylvania Medical Center (Data Collection Only)PhiladelphiaPennsylvania19104-4283
Susan Domchek, MD

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute (Data Collection Only)· Boston, MAMemorial Sloan-Kettering at Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering Nassau· Uniondale, NY

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