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Completed

NCT Number: NCT03067389

Combined Breast Cancer Risk Study

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.

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Key information

Conditions

Hereditary Cancer

Age range

18 year–84 year

Sex eligibility

Female

Study type

Observational

Primary location

The Breast Center of Northwest Arkansas, Fayetteville, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Test

Diagnostic Test

Genetic diagnostic test

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

    Time frame: Baseline

Secondary outcomes

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

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Myriad Genetic Laboratories, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2017
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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