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.

Namida Lab1 site in 1 country1,500 target enrollmentOctober 1, 2021

ConditionsBreast Cancer Screening

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer Screening
Sponsor: Namida Lab
Enrollment: 1500
Locations: 1
Primary Endpoint: Accuracy Measure
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2021

End Date

October 2024

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Namida Lab

Responsible Party

Sponsor

Eligibility Criteria

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