Clinical trial NCT04928014: Validation of a Tear-based Screening Assay for Breast Cancer
Official title: Validation of a Tear-based Screening Assay for Breast Cancer as a Supplemental Tool to Screening Mammograms
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Namida Lab
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of a tear-based biological test
timeFrame: 3 years
Secondary outcomes:
measure: Defining clinical utility of a tear-based biological test
timeFrame: 3 years
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Namida Lab
state: Arkansas
Study officials:
References: