Combined Breast Cancer Risk Study

Hereditary Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067389
• Other study ID #: HCP-018
• Status: Completed
• Start date: February 6, 2016
• Est. completion date: January 8, 2019

Study information

• Verified date: January 2019
• Source: Myriad Genetic Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 553
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Cancer

Intervention

Diagnostic Test:
• Diagnostic test
Genetic diagnostic test

Locations

Country	Name	City	State
United States	Bethesda Health	Boynton Beach	Florida
United States	The Breast Center of Northwest Arkansas	Fayetteville	Arkansas
United States	Cuda Women's Health Center	Hyannis	Massachusetts
United States	Elizabeth Wende Breast Care	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To derive a distribution of polygenic risk scores in an unselected patient population		baseline