DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

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 goal will be accomplished by recruiting 500 smokers with
indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic
bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic
performance of four previously established lung cancer biomarkers in this cohort will be
validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a
proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured
in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to
clinical and imaging markers routinely used in the diagnostic work up of these patients and
develop an integrated model (i.e. clinical, imaging & molecular markers) that results in the
most robust diagnostic predictor will be evaluated.

Inclusion Criteria:

- 45 years of age or older;

- Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);

- Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of
packs per day X number of years smoked)

- 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 minimum of two years;

- Able to fill out Patient Lung History questionnaire;

- Willing and able to provide a written informed consent.

Exclusion Criteria:

- History or previous diagnosis of lung cancer;

- Diagnosis of pure ground glass opacities on chest CT;

- Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative
nasal disease, hemodynamic instability, severe obstructive airway disease, unstable
cardiac or pulmonary disease; inability to protect airway or altered level of
consciousness;

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