Recruiting

Breast Cancer Test

Sponsor:

Namida Lab

Code:

NCT05268224

Conditions

Breast Cancer Screening

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Schirmer Strip

Study Details

Brief summary:

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.

Conditions

Breast Cancer Screening

Study ID

NCT05268224

Start date

Oct 1, 2021

Status verified date

Dec, 2023

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Dense Breast

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

Interventions

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.

Primary outcome measure

  • Accuracy Measure [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Anna Daily, PhD

4793342831anna@namidalab.com

Prashanth Ravishankar, PhD

4793342828prashanth@namidalab.com

Locations

Namida Lab

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Anna Daily, PhD

479-334-2828anna@namidalab.com

More Information

Sponsor

Namida Lab

Last update posted

Dec 11, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Namida Lab on 2023-12-11.