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

NCT05268224 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2023-12-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Namida Lab

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268224 on ClinicalTrials.gov