Combined Breast Cancer Risk Study

Sponsor

Myriad Genetic Laboratories, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03067389

Collaborator

(none)

553

Enrollment

Locations

35.1

Actual Duration (Months)

138.3

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Cancer	Diagnostic Test: Diagnostic test

Detailed Description

This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.

Study Design

Study Type:

Observational

Actual Enrollment :

553 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Evaluation of a Combined Breast Cancer Risk Derived From a Polygenic Risk Score and the Tyrer-Cuzick Model

Actual Study Start Date :

Feb 6, 2016

Actual Primary Completion Date :

Jan 8, 2019

Actual Study Completion Date :

Jan 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
History of invasive breast cancer Subjects with a diagnosis of invasive breast cancer within the past 12 months will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history.	Diagnostic Test: Diagnostic test Genetic diagnostic test
No history of invasive breast cancer Subjects with no history of breast cancer will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history.	Diagnostic Test: Diagnostic test Genetic diagnostic test

Arm

Intervention/Treatment

History of invasive breast cancer

Subjects with a diagnosis of invasive breast cancer within the past 12 months will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history.

Diagnostic Test: Diagnostic test

Genetic diagnostic test

No history of invasive breast cancer

Subjects with no history of breast cancer will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history.

Diagnostic Test: Diagnostic test

Genetic diagnostic test

Outcome Measures

Primary Outcome Measures

To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone [Baseline]

Secondary Outcome Measures

To derive a distribution of polygenic risk scores in an unselected patient population [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 84 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women without breast cancer:

18 to 84 years of age
Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
No history of invasive breast cancer

Women with a history of breast cancer:

18 to 84 years of age
Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
Pathologically confirmed invasive breast cancer diagnosed within the past 12 months

Exclusion Criteria:

Unwilling to provide written informed consent
Women with history of ductal carcinoma in situ (DCIS).
Patient has had a prior breast biopsy, exclusive of a breast biopsy diagnostic of breast cancer, that showed either hyperplasia, atypical hyperplasia, lobular carcinoma in situ (LCIS), or the specific histologic result is unknown to the patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Breast Center of Northwest Arkansas	Fayetteville	Arkansas	United States	72703
2	Bethesda Health	Boynton Beach	Florida	United States	33437
3	Cuda Women's Health Center	Hyannis	Massachusetts	United States	02601
4	Elizabeth Wende Breast Care	Rochester	New York	United States	14620

Sponsors and Collaborators

Myriad Genetic Laboratories, Inc.

Investigators

Study Director: John Holmsn, MD, Myriad Genetics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Myriad Genetic Laboratories, Inc.

ClinicalTrials.gov Identifier:

NCT03067389

Other Study ID Numbers:

HCP-018

First Posted:

Mar 1, 2017

Last Update Posted:

Jan 15, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 15, 2019