CClinicalTrials.gg
Active, not recruitingNCT04974567Updated Dec 11, 2023

Tear Based Sample Collection Breast Cancer Detection

An observational study in Breast Cancer, Tear and Breast Cancer Female, sponsored by Namida Lab. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Namida Lab · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 100 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Tear
  • Breast Cancer Female

Browse trials for

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
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 50 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Namida Lab is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

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

    Tear sample collection

    Other: Schirmer Strip

Interventions

  • OtherSchirmer 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.

06

What researchers measure

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.

    Time frame: 90 days

07

Study locations

1 site
  • UTMB Health
    Galveston, Texas 77555-0737, United States
08

References and documents

Study documents

  • Study protocol · Apr 13, 2021
  • Informed consent form · Apr 28, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD will not be shared or made available to other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04974567
Lead sponsor
Namida Lab
Collaborators
The University of Texas Medical Branch, Galveston
Responsible party
Sponsor
First posted
Jul 23, 2021
Start date
Apr 28, 2021
Primary completion
Aug 31, 2024 (estimated)
Completion
Sep 15, 2025 (estimated)
Last update
Dec 11, 2023

Study contacts

Suzanne Klimberg, MD, PhD
principal investigator · UTMB Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion