Validation of a Tear-based Screening Assay for Breast Cancer

Namida Lab

Status: Invitation-only

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

Treatments: Other: Schirmer Strip

Study type: Observational

Funder types: Industry

Identifiers

NCT04928014

Namida_001

PRO00053749 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

205 participants in 1 patient group

Screening Mammogram

Description:

Individuals eligible for a screening mammogram.

Treatment:

Other: Schirmer Strip