Actively Recruiting
Collection of Sputum and Labeling for Lung Cancer
Led by bioAffinity Technologies Inc. · Updated on 2025-04-01
500
Participants Needed
3
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Collection of Sputum and Labeling for Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- 21 years of age or older
- Willing to provide primary care physician contact information and agree to medical information release if needed
- Fit into one of the three study groups:
- Healthy Cohort: Current non-smoker with less than 5 pack-years smoking history or quit over 15 years ago, no known lung disease
- High Risk Cohort: Age 55-74, current smoker with at least 30 pack-years or former smoker with at least 30 pack-years who quit within 15 years
- Cancer Cohort: Diagnosed as highly suspect for lung cancer but not yet biopsied or treated, confirmed lung cancer by biopsy after sputum sample
You will not qualify if you...
- Severe obstructive lung disease preventing coughing up sputum
- Angina with minimal exertion
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Atlantic Respiratory Institute
Summit, New Jersey, United States, 07901
Actively Recruiting
2
Radiology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
3
South Texas Veterans Health Care System (STVHCS)/Audie L. Murphy Memorial Veterans Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Maria Zannes, JD
CONTACT
X
Xavier Reveles, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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