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Observational Study: Sputum Collection for Lung Cancer Detection

This observational study aims to improve how we detect lung cancer by analyzing sputum (phlegm) samples. Researchers are comparing a new test, called the Assay, with current methods for diagnosing lung cancer. They will collect sputum from healthy people, individuals at high risk for lung cancer, and those already diagnosed. The study will also look at different ways to collect sputum samples to find the best method. The goal is to refine the Assay design for future clinical trials and commercial use. You can join if you are 21 or older and meet the criteria for one of the three groups.

Study design
This is an observational study involving 500 participants across multiple centers. It compares a new test with standard diagnostic methods for lung cancer.
What's involved
You would provide a sputum sample. If you are in the high-risk group, you would also undergo low-dose computed tomography (LDCT) scans.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, identification of differential characteristics, is measured at 320 days.

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NCT03457415

Collection of Sputum and Labeling for Lung Cancer

Recruiting
Not specifiedAges 21+Observational
bioAffinity Technologies Inc.
~500 participants
Updated 2025-04-01 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of Differential Characteristics
Measured over 320 days

Conditions

Lung Cancer

Explore related trials

Lung Carcinoma

Where it's being run

3 sites across 3 states
New Jersey1
New Mexico1
Texas1

Who to contact

Maria Zannes, JD
[email protected]
505-400-9747
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Eligibility criteria

Inclusion

Male or female
21 years of age or older
Willing to provide primary care physician contact information to the investigator and agree to have medical information released if indicated
Meet requirements of one of three cohorts in the study:

Exclusion

Severe obstructive lung disease and unable to cough with sufficient exertion to produce a sputum sample. Participants with lung disease that are able to cough with sufficient exertion to produce a sputum sample are not excluded from the study
Angina with minimal exertion
Pregnancy

What this trial measures

  • Identification of Differential Characteristics320 days

    The primary outcome measure is to identify differential characteristics (using flow cytometry for high-throughput screening of Assay labeled sputum samples) between samples taken from healthy Participants, Participants at high risk for lung cancer who are free of the disease, and Participants with confirmed lung cancer.