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NCT04974567 Clinical Trial

Tear Based Sample Collection Breast Cancer Detection

Breast Cancer Clinical Trial

Official title:
Tear Based Sample Collection for Breast Cancer Detection

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04974567
Other study ID # IRB # 21-0026
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 28, 2021
Est. completion date September 15, 2025

Study information
Verified date December 2023
Source Namida Lab
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date September 15, 2025
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Schirmer 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.

Locations
Country Name City State
United States UTMB Health Galveston Texas

Sponsors (2)
Lead Sponsor Collaborator
Namida Lab The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 90 days
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