A tear-based test for breast cancer in 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.
This study is testing a new tear-based test to help women with dense breast tissue get better screening for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Namida Lab Industry-sponsored |
| Locations | 1 site (Fayetteville, Arkansas) |
| Trial ID | NCT05268224 on ClinicalTrials.gov |
What this trial studies
This observational study investigates a lab-developed biological test that analyzes tears to aid in breast cancer screening for women with dense breast tissue. The test, designed and validated by Namida Lab, Inc., aims to serve as a supplemental tool alongside existing screening methods. Participants will use a Schirmer Strip to collect tear samples, which will be analyzed to determine the presence of breast cancer. The study focuses on women aged 18 and older who have been categorized with heterogeneously dense or extremely dense breast tissue.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with heterogeneously dense or extremely dense breast tissue.
Not a fit: Patients with active eye infections, those with fatty breast tissue, or currently diagnosed with breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this test could provide a non-invasive and effective screening option for early detection of breast cancer in women with dense breast tissue.
How similar studies have performed: While this approach is innovative, it is not widely tested in similar studies, making it a novel exploration in breast cancer screening.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Where this trial is running
Fayetteville, Arkansas
- Namida Lab — Fayetteville, Arkansas, United States (Recruiting)
Study contacts
- Study coordinator: Anna Daily, PhD
- Email: anna@namidalab.com
- Phone: 4793342831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.