Validation of a Tear-based Screening Assay for Breast Cancer

• Conditions: Health Care Utilization; Health Knowledge, Attitudes, Practice; Healthy; Health Personnel Attitude; Breast Cancer; Breast Cancer Female; Health Care Acceptability
• Interventions: Other: Schirmer Strip

• Registration Number: NCT04928014
• Lead Sponsor: Namida Lab

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-16
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03
• Primary Completion: 2023-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 205

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening Mammogram	Schirmer Strip	Individuals eligible for a screening mammogram.

Primary Outcome Measures

Name	Time	Method
Validation of a tear-based biological test	3 years	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

Secondary Outcome Measures

Name	Time	Method
Defining clinical utility of a tear-based biological test	3 years	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.

Trial Locations

Locations (1)

Namida Lab; 🇺🇸 Fayetteville, Arkansas, United States