Clinical Trials

Inclusion Criteria:

• Self-report routine sputum production.

• Adults, 18 to 89 years of age.

• Smoking history of 1 pack year or more.

• Referred to a specialist for evaluation of 1 or more (up to 10) documented lung nodule(s) ≥ 6 mm on imaging with an available report (Lung Cancer/Suspected Lung Cancer) -OR- Any benign lung disease, such as COPD, emphysema, pneumonia, etc. (Benign Lung Disease)  -OR-“Normal” is defined as participants with no active lung cancer, suspected lung cancer or active lung disease (Normal)

• Able to collect sputum at home before invasive lung procedure (bronchoscopy, biopsy, surgery) for the Lung Cancer/Suspected Lung Cancer and Benign Lung Disease groups.

• Participants will be able and willing to provide informed consent.

Exclusion Criteria:

• Known HIV+

• Current known cancer of any etiology except for primary lung cancer within the last five years.

• Known lung metastases of extra-pulmonary origin.

• Prisoners.

• Cognitively impaired adults.

• Pregnant/lactating women.

• Non-English-speaking participants (Note-this exclusion was added to facilitate the limited objective of this study. This exclusion would be eliminated in a trial to fully explore this cohort, for example, in the context of a trial intended to secure FDA clearance for the LuCED test).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/16/2025. Questions regarding updates should be directed to the study team contact.