Breast Cancer
Conditions
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.
Interventions
None listed
Sponsors
Luminist, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with untreated newly diagnosed breast cancer. | 1 Year |
Countries
United States
Contacts
Primary ContactStorm Stillman
Backup ContactWill Olsen
Outcome results
None listed