Tear Based Sample Collection Breast Cancer Detection

December 7, 2023 updated by: Namida Lab

Tear Based Sample Collection for Breast Cancer Detection

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555-0737
        • UTMB Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The Tear Based Breast Cancer Detection study participants are all women, born biologically female, with a recent diagnosis of breast cancer, have not started treatment, and are between the ages of 18 to 100 years old.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women recently diagnosed with breast cancer who have not undergone any treatment.
Tear sample collection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participant tear samples collected.
Time Frame: 90 days
The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Namida Lab

Collaborators

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Suzanne Klimberg, MD, PhD, UTMB Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 21-0026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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