Tear Based Sample Collection Breast Cancer Detection

Namida Lab50 enrolled

Overview

This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Tear Breast Cancer Female

Interventions

Schirmer StripOTHER

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

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

UTMB Health

Galveston, Texas, United States

Outcomes

Primary Outcomes

Number of participant tear samples collected.

The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer.

Time frame: 90 days

Data from ClinicalTrials.gov

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