A Multicenter Breast Cancer Biospecimen Registry

• Conditions: Breast Cancer

• Registration Number: NCT02712645
• Lead Sponsor: Luminist, Inc.

Brief Summary

This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 700

Inclusion Criteria

1. Females of all racial and ethnic groups who are 40 years or older.

2. Women must:

   1. have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
   2. be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.

Exclusion Criteria

1. Inability to sign informed consent.
2. More than one radiological finding.
3. Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
4. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
5. Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
6. Received any experimental therapeutic treatment during the previous 3 months.
7. Received any blood product transfusion within the previous 3 months.
8. Use of illegal drugs during the previous 3 months.
9. Pregnant or nursing at the time of enrollment or in the preceding 12 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with untreated newly diagnosed breast cancer.	1 Year