Detection of Early lung Cancer Among Military Personnel Study 1 (DECAMP-1):
Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Protocol Documents

Protocol Summary [PDF]

Principal Investigators:  Avrum Spira, MD, MSc, and Mitchell Schnall, MD, PhD

Status:  Open

Limited Site Participation: 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 3 academic hospitasl as clinical study sites, several molecular biomarker laboratories,
along with Biostatistics, Bioinformatics, Pathology, and Biorepository cores.

Overview: The DECAMP-1 trial is supported through the Department of Defense (DoD) and
funded through the DoD Lung Cancer Research Program. In this study, four previously-established
lung cancer biomarkers will be assessed for future validation.

Main Objective: The main objective of this trial is to improve the efficiency of the diagnostic
evaluation of patients with indeterminate pulmonary nodules. The trial will determine the diagnostic
accuracy of biomarkers for lung cancer measured in minimally-invasive and non-invasive biospecimens,
and whether these genomic and proteomic biomarkers in the airway and blood can distinguish between
high-risk smokers with malignant or benign indeterminate, incidentally-detected pulmonary nodules.

Participants: Patients enrolled will be 45 years or older, have been diagnosed with indeterminate
pulmonary nodules within the year prior to enrollment (size at time of consent must be: 0.7 to 3.0 cm),
and have a smoking status as a current or former smoker with ≥20 pack years (pack years = number
of packs per day X number of years smoked).

Study Design Summary: A total of 500 former or current smokers with a minimum of
20 pack-years of smoking and indeterminate pulmonary nodule(s) on chest CT will be recruited
to the trial. Each participant will undergo fiberoptic bronchoscopy, have blood and urine collected,
provide sputum and cellular samples, and complete a questionnaire. Imaging studies completed during
the trial will be submitted to the American College of Radiology Imaging Core Laboratory. Follow-up
will comprise standard-of-care practices per institutional norms over two years to allow for diagnosis
of indeterminate pulmonary nodules.