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 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.

Sex

All

Minimum age

21 Years

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this study:

* 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:

Healthy Cohort: Current non-smoker who has smoked less than 5 pack-years in his or her lifetime, and if smoked, quit more than 15 years ago, and has no known lung disease.

High Risk Cohort: Individual aged ≥55-74 who is a current smoker with a smoking history of at least 30 pack-years, or current non-smoker who has a smoking history of at least 30 pack-years, and quit smoking within the past 15 years.

Cancer Cohort: Individual who has been diagnosed by a physician as highly suspect for having lung cancer but has not yet undergone a biopsy nor received therapy, and after providing a sputum sample is confirmed to have lung cancer by biopsy.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from the study:

* 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

• RESULTBederka LH, Sanchez JR, Rebeles J, Araujo PR, Grayson MH, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Humphreys J, Reveles XT, Rebel VI. Sputum analysis by flow cytometry; an effective platform to analyze the lung environment. PLoS One. 2022 Aug 17;17(8):e0272069. doi: 10.1371/journal.pone.0272069. eCollection 2022. PMID 35976857
• RESULTGrayson M, Lai SC, Bederka LH, Araujo P, Sanchez J, Reveles XT, Rebel VI, Rebeles J. Quality-Controlled Sputum Analysis by Flow Cytometry. J Vis Exp. 2021 Aug 9;(174). doi: 10.3791/62785. PMID 34424239
• RESULTLemieux ME, Reveles XT, Rebeles J, Bederka LH, Araujo PR, Sanchez JR, Grayson M, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Joyce RP, Rebel VI. Detection of early-stage lung cancer in sputum using automated flow cytometry and machine learning. Respir Res. 2023 Jan 21;24(1):23. doi: 10.1186/s12931-023-02327-3. PMID 36681813