Tear Based Sample Collection Breast Cancer Detection

NCT04974567 | Unknown

• 1 other identifier: IRB # 21-0026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Tear; Breast Cancer Female

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participant tear samples collected.

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

  90 days

Study Arms (1)

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

Tear sample collection

Other: Schirmer Strip

Interventions

Schirmer Strip 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.

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Individual is an adult woman and has recently been diagnosed with breast cancer.

You may not qualify if:

• Individual is excluded if they have already started treatment for the breast cancer diagnosis.
• Age less than 18 or more than 100 years.

Sponsors & Collaborators

• Namida Lab: lead
• The University of Texas Medical Branch, Galveston: collaborator

Study Sites (1)

UTMB Health

Galveston, Texas, 77555-0737, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lacrimal (tear) fluid

MeSH Terms

Conditions

Breast Neoplasms; Lacerations

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Suzanne Klimberg, MD, PhD

  UTMB Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 23, 2021
• Study Start: April 28, 2021
• Primary Completion: August 31, 2024
• Study Completion: September 15, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)