Tear Based Sample Collection Breast Cancer Detection

Namida Lab

Status: Active, not recruiting

Conditions: Breast Cancer; Breast Cancer Female; Tear

Treatments: Other: Schirmer Strip

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04974567

IRB # 21-0026

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Women recently diagnosed with breast cancer who have not undergone any treatment.

Description:

Tear sample collection

Treatment:

Other: Schirmer Strip