Breast Cancer Screening
Conditions
Brief summary
Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. The test was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Interventions
DIAGNOSTIC_TESTSchirmer Strip
A tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA-certified lab. It consists of two parts: tear sample collection using a Schirmer Strip and a clinical lab-developed test that measures protein biomarkers for breast cancer screening.
Sponsors
Namida Lab
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Categorized as having heterogeneously dense or extremely dense tissue 18 years of age or older Able to understand the informed consent process Willing to comply with all study procedures
Exclusion criteria
Have an active eye infection Categorized as having fibro glandular densities or fatty breast tissue Currently diagnosed or are receiving treatment for breast cancer Under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy Measure | 3 months | Degree of closeness of categorization by a tear-based biological test scores to imaging techniques |
Countries
United States
Contacts
Primary ContactAnna Daily, PhD
Backup ContactPrashanth Ravishankar, PhD
Outcome results
None listed