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NCT05268224 Clinical Trial

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

Breast Cancer Screening Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05268224
Other study ID # IRB#2022-0073
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date October 2024

Study information
Verified date December 2023
Source Namida Lab
Contact Anna Daily, PhD
Phone 4793342831
Email anna@namidalab.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Namida Lab Fayetteville Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Namida Lab

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy Measure Degree of closeness of categorization by a tear-based biological test scores to imaging techniques 3 months
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