DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer

The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a
multidisciplinary and translational research program that includes 7 Veterans Administration
Hospitals (VAH), the 4 designated Military Treatment Facilities (MTF) and 4 academic
hospitals as clinical study sites, several molecular biomarker laboratories, along with
Biostatics, Bioinformatics, Pathology and Biorepository cores. The DECAMP Coordinating Center
will facilitate rapid selection, design and execution of clinical studies within this
multi-institutional consortium. The ACRIN 4704 study will recruit one cohort to achieve the
aims of this study: a longitudinal screening cohort.

Inclusion Criteria for longitudinal screening cohort

- Ages 50 to 79 years;

- Smoking status: Current or former smoker (≥10 cigarettes/day for current smokers, or
≥20 pack years for former smoker who quit 20 years ago or less)

- History of Chronic Obstructive Pulmonary Disease (COPD), emphysema, or at least one
first-degree relative with a diagnosis of lung cancer;

- Willing to undergo fiberoptic bronchoscopy;

- Able to tolerate all biospecimen collection as required by protocol;

- Able to comply with standard-of-care follow-up visits, including clinical exams,
diagnostic work-ups, and imaging for a maximum of four years or until diagnosis of
lung cancer;

- Able to fill out Patient Lung History questionnaire;

- Willing and able to provide a written informed consent.

Exclusion Criteria

- Diagnosis of lung cancer prior to the current assessment (that is, patients are
eligible if first lung cancer diagnosis has been recently confirmed by bronchoscopic
biopsy and is leading to resection surgery, but not if this is not a first diagnosis);

- Contraindications to nasal brushing or fiberoptic bronchoscopy, including: ulcerative
nasal disease, hemodynamic instability, severe obstructive airway disease (i.e.,
disease severity does not allow for bronchoscopic procedures), unstable cardiac or
pulmonary disease, as well as other comorbidities leading to inability to protect
airway, or altered level of consciousness;

- Allergies to any local anesthetic that may be used to obtain biosamples in the study;

- Weight greater than that allowable by the CT scanner.