A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue

Namida Lab

Status: Enrolling

Conditions: Breast Cancer Screening

Treatments: Diagnostic Test: Schirmer Strip

Study type: Observational

Funder types: Industry

Identifiers

NCT05268224

IRB#2022-0073

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Dense Breast

Description:

Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.

Treatment:

Diagnostic Test: Schirmer Strip