NCT05268224

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Namida Lab · Industry
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Screening

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Schirmer 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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2022-03-07
• Last updated: 2023-12-11

Locations

1 site across 1 country: United States