- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396341
Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
February 19, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jada Hamilton, PhD, MPH
- Phone Number: 646-888-0049
- Email: hamiltoj@mskcc.org
Study Contact Backup
- Name: Mark Robson, MD
- Phone Number: 646-888-5486
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Dana Farber Cancer Institute (Data Collection Only)
-
Contact:
- Judy Garber, MD, MPH
- Phone Number: 617-632-5961
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan-Kettering at Basking Ridge
-
Contact:
- Jada Hamilton, PhD, MPH
- Phone Number: 646-888-0049
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
-
Contact:
- Jada Hamilton, PhD, MPH
- Phone Number: 646-888-0049
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
-
Contact:
- Jada Hamilton, PhD, MPH
- Phone Number: 646-888-0049
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Jada Hamilton, PhD, MPH
- Phone Number: 646-888-0049
-
Principal Investigator:
- Jada Hamilton, PhD, MPH
-
Contact:
- Mark Robson, MD
- Phone Number: 646-888-5486
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau
-
Contact:
- Jade Hamilton, PhD, MPH
- Phone Number: 646-888-0049
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104-4283
- Recruiting
- Abramson Cancer Center at University of Pennsylvania Medical Center (Data Collection Only)
-
Contact:
- Susan Domchek, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Potential participants (i.e., patients receiving a positive BRCA1/2 mutation result) will be identified and approached by their primary genetic counselor.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients that opt for preventive mastectomy or to pursue surveillance
Time Frame: 3 years
|
Hierarchical level modeling (HLM) will be implemented to assess the effect of genetic risk modifier testing on Decisional Conflict Scale score (DCS), allowing for baseline effects via a random intercept.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jada Hamilton, PhD, MPH, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 Major Dates
Study Start (Actual)
January 4, 2018
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
January 5, 2018
First Submitted That Met QC Criteria
January 5, 2018
First Posted (Actual)
January 10, 2018
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17-489
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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