Combined Breast Cancer Risk Study

Myriad Genetic Laboratories

Status: Completed

Conditions: Hereditary Cancer

Treatments: Diagnostic Test: Diagnostic test

Study type: Observational

Funder types: Industry

Identifiers

NCT03067389

HCP-018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 553 patients

Sex: Female

Ages: 18 to 84 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

553 participants in 2 patient groups

History of invasive breast cancer

Description:

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.

Treatment:

Diagnostic Test: Diagnostic test

No history of invasive breast cancer

Description:

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.

Treatment:

Diagnostic Test: Diagnostic test