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Tear Based Sample Collection Breast Cancer Detection

NCT ID: NCT04974567

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-28

Study Completion Date

2025-09-15

Brief Summary

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

Detailed Description

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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

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Breast Cancer Tear Breast Cancer Female

Keywords

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preventative screening protein biomarkers lacrimal tear fluid mammography ELISA assay CLIA laboratory lab developed test high complexity tear collection mammogram improved patient outcomes reduce gap in access health equity total cost of care trust from patient increased compliance affordable low cost non-invasive women's health and wellness breast health breast cancer screening test

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Tear sample collection

Schirmer Strip

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role collaborator

Namida Lab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suzanne Klimberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UTMB Health

Locations

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UTMB Health

Galveston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB # 21-0026

Identifier Type: -

Identifier Source: org_study_id