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Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03396341
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Phenogen Sciences
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Genetic Testing BRCA1/2 Other: Salvia sample Behavioral: Questionnaires

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Study Type : Observational
Estimated Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Salvia

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
Other: Salvia sample
salvia sample

Behavioral: 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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
saliva sample


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   BRACA 1/2 mutation carriers
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.
Criteria

Inclusion Criteria:

  • Female MSK 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396341


Contacts
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Contact: Jada Hamilton, PhD, MPH 646-888-0049 hamiltoj@mskcc.org
Contact: Mark Robson, MD 646-888-5486

Locations
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United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Jada Hamilton, PhD, MPH    646-888-0049      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Jada Hamilton, PhD, MPH    646-888-0049      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Jada Hamilton, PhD, MPH    646-888-0049      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jada Hamilton, PhD, MPH    646-888-0049      
Contact: Mark Robson, MD    646-888-5486      
Principal Investigator: Jada Hamilton, PhD, MPH         
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Jade Hamilton, PhD, MPH    646-888-0049      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Phenogen Sciences
Investigators
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Principal Investigator: Jada Hamilton, PhD, MPH Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03396341     History of Changes
Other Study ID Numbers: 17-489
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
BRCA1/2 Mutations
17-489