Tear Based Sample Collection Breast Cancer Detection

Active, not recruiting

• Conditions: Tear; Breast Cancer; Breast Cancer Female
• Interventions: Other: Schirmer Strip

• Registration Number: NCT04974567
• Lead Sponsor: Namida Lab

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.

Study Timeline

• Study Start: 2021-04-28
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-08-31
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women recently diagnosed with breast cancer who have not undergone any treatment.	Schirmer Strip	Tear sample collection

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UTMB Health; 🇺🇸 Galveston, Texas, United States