Validation of a Tear-based Screening Assay for Breast Cancer

NCT04928014 | Unknown

• 2 other identifiers: Namida_001PRO00053749
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Breast Cancer; Breast Cancer Female; Health Care Utilization; Health Knowledge, Attitudes, Practice; Health Personnel Attitude; Health Care Acceptability

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Defining clinical utility of a tear-based biological test

  3 years

Study Arms (1)

Screening Mammogram

Individuals eligible for a screening mammogram.

Other: Schirmer Strip

Interventions

Schirmer Strip OTHER

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.

Screening Mammogram

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Born biologically female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female over the age of 18 Able to undergo the informed consent process Willingness to comply with all study procedures

You may not qualify if:

• Currently diagnosed or are receiving treatment for breast cancer Have an active eye infection under 18 years of age

Sponsors & Collaborators

• Namida Lab: lead

Study Sites (1)

Namida Lab

Fayetteville, Arkansas, 72703, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lacrimal (tear) fluid

MeSH Terms

Conditions

Breast Neoplasms; Patient Acceptance of Health Care; Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)