Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Rupture

Lacerations

Breast Diseases

Skin Diseases

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.

Schirmer Strip

Suzanne Klimberg, MD, PhD

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.

Tear Based Sample Collection Breast Cancer Detection

Tear Based Sample Collection for Breast Cancer Detection

IPD will not be shared or made available to other researchers.

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

The University of Texas Medical Branch, Galveston

Namida Lab

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Herbal and Botanical

All Drugs and Chemicals

Cola

A tear sample (\~75 microliters in a tuberculin syringe with the needle removed) will be taken at time of the initial clinic visit. After collection, the tears will be put directly on ice and taken to the lab. If it is not possible to obtain natural tears, an "eye wash" method using sterile saline will be employed and the fluid collected using the aforementioned technique. The SELDI-MS process will be conducted on the specimen immediately. The remainder of the tear specimen will be stored in a -80ºC freezer until completely analyzed.

Tear collection

V. Suzanne Klimberg, MD

This study will further evaluate the use of protein identification or protein pattern (signature) found in tears. We hypothesize that differences exist between the protein profile in tear fluid from patients with versus without cancer.

Specifically, this study will compare the protein profile in tear fluid from patients with breast, ovarian or colon cancer versus "normal male and female patients" for differences that show promise as a diagnostic indicator. If such differences can be found, then their diagnostic potential will be assessed and developed further in a subsequent study. The long-term goal of this project will be to develop a screening tool for the detection of breast and/or other cancers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tear Based Sample Collection Breast Cancer Detection	NCT04974567	Breast Cancer Tear Breast Cancer F...	Schirmer Strip	18 Years - 100 Years	Namida Lab
Tear Based Sample Collection Breast Cancer Detection	NCT04974567	Breast Cancer Tear Breast Cancer F...	Schirmer Strip	18 Years - 100 Years	Namida Lab
Tear Based Sample Collection Breast Cancer Detection	NCT04974567	Breast Cancer Tear Breast Cancer F...	Schirmer Strip	18 Years - 100 Years	Namida Lab
Analyzing the Composition of Tears to Identify Cancer	NCT00574678	Breast Cancer Ovarian Cancer Colon Cancer Benign Disease	Tear collection	18 Years -	University of Arkansas

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