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A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue

NCT ID: NCT05268224

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

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-10-31

Brief Summary

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Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. The test was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Detailed Description

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Conditions

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Breast Cancer Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dense Breast

Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.

Schirmer Strip

Intervention Type DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Categorized as having heterogeneously dense or extremely dense tissue 18 years of age or older Able to understand the informed consent process Willing to comply with all study procedures

Exclusion Criteria

Have an active eye infection Categorized as having fibro glandular densities or fatty breast tissue Currently diagnosed or are receiving treatment for breast cancer Under 18 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Namida Lab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Namida Lab

Fayetteville, Arkansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna Daily, PhD

Role: CONTACT

Phone: 4793342831

Email: [email protected]

Prashanth Ravishankar, PhD

Role: CONTACT

Phone: 4793342828

Email: [email protected]

Facility Contacts

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Anna Daily, PhD

Role: primary

Other Identifiers

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IRB#2022-0073

Identifier Type: -

Identifier Source: org_study_id