A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
- Conditions
- Breast Cancer Screening
- Interventions
- Diagnostic Test: Schirmer Strip
- Registration Number
- NCT05268224
- Lead Sponsor
- Namida Lab
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1500
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dense Breast Schirmer Strip Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.
- Primary Outcome Measures
Name Time Method Accuracy Measure 3 months Degree of closeness of categorization by a tear-based biological test scores to imaging techniques
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Namida Lab
🇺🇸Fayetteville, Arkansas, United States