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Search / Trial NCT04928014

Validation of a Tear-based Screening Assay for Breast Cancer

Launched by NAMIDA LAB · Jun 15, 2021

Trial Information

Current as of August 19, 2025

Enrolling by invitation

Keywords

Preventative Screening Protein Biomarkers Lacrimal Tear Fluid Mammography Primary Care Elisa Assay Clia Laboratory Lab Developed Test Clinical Utility High Complexity Underserved Populations Health Disparities Tear Collection Mammogram Improved Patient Outcomes Reduces Gap In Access Health Equity Total Cost Of Care Trust From Patient Increased Compliance Affordable Non Invasive Women's Health And Wellness Breast Health Breast Cancer Screening Test

ClinConnect Summary

The primary objective of this study is to determine if a tear-based biological test is an effective option in breast cancer screening. This will be assessed by comparing the score and classification produced from the assay to the current gold standard, screening Mammograms.

The primary endpoint will be assessed by calculating the sensitivity, specificity, PPV, and NPV for the biological assay compared to the results of imaging.

The secondary objective of this study is to obtain provider insight and recommendation as to the potential clinical utility of a tear-based biological test as a br...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Female over the age of 18 Able to undergo the informed consent process Willingness to comply with all study procedures
  • Exclusion Criteria:
  • Currently diagnosed or are receiving treatment for breast cancer Have an active eye infection under 18 years of age

About Namida Lab

Namida Lab is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on transformative therapies, Namida Lab collaborates with leading institutions and experienced professionals to conduct rigorous clinical trials that address unmet medical needs. Their commitment to scientific excellence and patient-centric approaches ensures the development of safe and effective treatments, ultimately aiming to enhance the quality of life for individuals worldwide. Through a combination of cutting-edge technology and a multidisciplinary team, Namida Lab strives to accelerate the delivery of breakthrough solutions in the pharmaceutical and biotechnology sectors.

Locations

Fayetteville, Arkansas, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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