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NCT03457415 · ClinicalTrials.gov registry record
Collection of Sputum and Labeling for Lung Cancer
A clinical trial of Lung Cancer, sponsored by bioAffinity Technologies.
- Recruiting
- Registry status
- 500
- Enrollment target
- 3
- Study locations
NCT03457415: Recruiting study of Lung Cancer, sponsored by bioAffinity Technologies.
NCT03457415 is a study of Lung Cancer that is actively recruiting participants, run by bioAffinity Technologies. The registered enrollment target is 500 participants, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (47% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03457415, a study of Lung Cancer, is actively recruiting participants, sponsored by bioAffinity Technologies.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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.
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 |
What NCT03457415 shows while recruiting
NCT03457415 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT03457415 reports a single indexed study location in New Jersey, New Mexico, Texas.
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.
Who is sponsoring clinical trial NCT03457415?
This trial is sponsored by bioAffinity Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03457415's enrollment target sits among peer trials
500 70th of 409 higher than 338 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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