Validation of a Tear-based Screening Assay for Breast Cancer

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy; Breast Cancer; Health Knowledge, Attitudes, Practice; Health Care Utilization; Breast Cancer Female; Health Personnel Attitude; Health Care Acceptability
• Intervention / Treatment: Other: Schirmer Strip

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 Type: Observational
• Enrollment (Estimated): 205

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Namida Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will be primarily women over the age of 35 who participate in yearly screening mammography. There are instances where a screening mammogram is given under the age of 35, therefore the enrollment age has been set at 18 years of age or older. Participants will be recruited from participating clinical sites which would include breast radiology speciality clinics, OB/GYN practice, internal medicine clinics, and primary care clinics.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Screening Mammogram; Individuals eligible for a screening mammogram.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Namida Lab

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: primary care; non-invasive; health disparities; underserved populations; mammography; mammogram; health equity; clinical utility; affordable; preventative screening; protein biomarkers; lacrimal tear fluid; ELISA assay; CLIA laboratory; lab developed test; high complexity; tear collection; improved patient outcomes; reduces gap in access; total cost of care; trust from patient; increased compliance; women's health and wellness; breast health; breast cancer screening test
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Namida_001; PRO00053749 (Other Identifier: Advarra IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No