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NCT04928014 Clinical Trial

Validation of a Tear-based Screening Assay for Breast Cancer

Healthy Clinical Trial

Official title:
Validation of a Tear-based Screening Assay for Breast Cancer as a Supplemental Tool to Screening Mammograms

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04928014
Other study ID # Namida_001
Secondary ID PRO00053749
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 2025

Study information
Verified date June 2023
Source Namida Lab
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will explore and better understand the value, usage, and benefits of a tear-based screening test for breast cancer as a supplemental tool for screening mammograms. This tear-based screening test was developed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Description:

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 breast cancer screening option. The secondary endpoint will be achieved through a provider roundtable discussion. After completion of enrollment and evaluation of tear samples and time will be arranged, either in person or virtual, to review the test scores determined for the sites patient population. Providers will be allowed to verbally review the process and give their thoughts on the utility of a tear-based biological test within their clinic and how they feel it should be used. A member of the Namida Lab clinical team will be present to take notes. After the discussion a report will be generated and the site providers will be allowed to review it for accuracy. Sites will be given a copy of their participants' scores as well as a summary of the provider roundtable discussion. Sites may request to have the participants' results blinded if prior to review if preferred.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 205
Est. completion date December 2025
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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 Validation of a tear-based biological test The primary endpoint will be assessed by calculating the sensitivity, specificity, PPV, and NPV for the a tear-based biological test compared to results of imaging 3 years
Secondary Defining clinical utility of a tear-based biological test 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 breast cancer screening option. 3 years
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