Breast Cancer, Breast Cancer Female, Tear
Conditions
Keywords
preventative screening, protein biomarkers, lacrimal tear fluid, mammography, ELISA assay, CLIA laboratory, lab developed test, high complexity, tear collection, mammogram, improved patient outcomes, reduce gap in access, health equity, total cost of care, trust from patient, increased compliance, affordable, low cost, non-invasive, women's health and wellness, breast health, breast cancer screening test
Brief summary
This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.
Detailed description
Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.
Interventions
OTHERSchirmer Strip
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.
Sponsors
The University of Texas Medical Branch, Galveston
Namida Lab
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Individual is an adult woman and has recently been diagnosed with breast cancer.
Exclusion criteria
* Individual is excluded if they have already started treatment for the breast cancer diagnosis. * Age less than 18 or more than 100 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participant tear samples collected. | 90 days | The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer. |
Countries
United States
Outcome results
None listed