NCT04974567

Tear Based Sample Collection Breast Cancer Detection

Tear Based Sample Collection for Breast Cancer Detection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Namida Lab · Industry
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Tear
• Breast Cancer Female

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-28
• Primary completion: 2024-08-31
• Completion: 2025-09-15
• First posted: 2021-07-23
• Last updated: 2023-12-11

Locations

1 site across 1 country: United States