A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
Investigation of a Tear-based, Lab-developed Biological Test for Breast Cancer, as a Supplemental Tool to Current Screening Recommendations for Women With Dense Breast Tissue.
1 other identifier
observational
1,500
1 country
1
Brief Summary
Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. The test was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedDecember 11, 2023
December 1, 2023
3 years
February 24, 2022
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy Measure
Degree of closeness of categorization by a tear-based biological test scores to imaging techniques
3 months
Study Arms (1)
Dense Breast
Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.
Interventions
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.
Eligibility Criteria
Women who have been mammographically catagorized as having heterogenously dense or extremely dense breast tissue.
You may qualify if:
- Categorized as having heterogeneously dense or extremely dense tissue 18 years of age or older Able to understand the informed consent process Willing to comply with all study procedures
You may not qualify if:
- Have an active eye infection Categorized as having fibro glandular densities or fatty breast tissue Currently diagnosed or are receiving treatment for breast cancer Under 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Namida Lablead
Study Sites (1)
Namida Lab
Fayetteville, Arkansas, 72703, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2022
First Posted
March 7, 2022
Study Start
October 1, 2021
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
December 11, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
Individual participant data is not intended to be shared with other researchers at this time.