Collection of Sputum and Labeling for Lung Cancer

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