Combined Breast Cancer Risk Study

NCT03067389 | Completed

• 1 other identifier: HCP-018
• Study Type: observational
• Target: 553
• Locations: 1 country
• Sites: 4

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.

Conditions

Hereditary Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To derive a distribution of polygenic risk scores in an unselected patient population

  baseline

Study Arms (2)

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

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

Interventions

Diagnostic test DIAGNOSTIC_TEST

Genetic diagnostic test

History of invasive breast cancer; No history of invasive breast cancer

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women presenting at imaging centers for a breast cancer diagnostic assessment visit or preventative screening visit.

You may qualify if:

• Women without breast cancer:
• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead

Study Sites (4)

The Breast Center of Northwest Arkansas

Fayetteville, Arkansas, 72703, United States

Location

Bethesda Health

Boynton Beach, Florida, 33437, United States

Location

Cuda Women's Health Center

Hyannis, Massachusetts, 02601, United States

Location

Elizabeth Wende Breast Care

Rochester, New York, 14620, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and saliva

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• John Holmsn, MD

  Myriad Genetics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: February 6, 2016
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)