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Collection of Sputum and Labeling for Lung Cancer
NCT03457415 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Participants using the Assay as developed in accordance with findings of bioAffinity protocol BA-001 to confirm assay results. Adjustments will be made as necessary to finalize Assay design for clinical trials and commercialization. The secondary objective of this study is to determine optimum methods for collection of sputum samples. Three sputum collection methods used by high risk Participants will be compared. Individuals at high risk for lung cancer will be assigned to one of three sputum collection cohorts including (1) acapella® airway assist device under medical supervision to obtain a single sputum sample; (2) acapella® airway assist device to obtain a sputum sample over a three-day period, and (3) individuals who under medical supervision will collect a single sputum sample assisted by nebulization of between 0.9% to 10% hypertonic saline. Samples will be compared to determine the optimal collection method for sample analysis by CyPath® Lung.
Conditions Studied
Study Locations (3)
New Jersey
- Atlantic Respiratory Institute — Summit
New Mexico
- Radiology Associates of Albuquerque — Albuquerque
Texas
- South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2025-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03457415
The ClinicalTrials.gov registry entry for NCT03457415 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is bioAffinity Technologies, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03457415 reports 3 study locations spanning 3 distinct geographic areas — top geographies include New Jersey, New Mexico, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03457415 about?
NCT03457415 is a clinical study titled "Collection of Sputum and Labeling for Lung Cancer". The primary objective of this study is to compare Assay results to diagnoses determined by currently accepted standards for lung cancer detection. This will be accomplished by analysis of sputum samples from three cohorts including healthy Participants, high risk Participants, and cancer patient Par...
What is the current status of trial NCT03457415?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2018-03-01. Estimated completion is 2025-12.
What conditions does trial NCT03457415 study?
This clinical trial studies the following conditions: Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT03457415?
This trial is sponsored by bioAffinity Technologies, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03457415 being conducted?
This trial has 3 study locations across New Jersey, New Mexico, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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