Protocol Specific Materials
ACRIN 4704 DECAMP Study 2

Detection of Early lung Cancer Among Military Personnel Study 2 (DECAMP-2):
Screening of Patients with Early Stage Lung Cancer or at High Risk
for Development of Lung Cancer

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 2 academic hospitals as clinical study sites, several molecular biomarker laboratories,
along with Biostatistics, Bioinformatics, Pathology, and Biorepository cores.

Overview: The DECAMP-2 trial is supported through the Department of Defense (DoD) and
funded through the DoD Lung Cancer Research Program. In this study, the goal is to improve
lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and
disease risk that are measured in minimally invasive and non-invasive biospecimens. Existing
biomarkers for lung cancer diagnosis, as well as new biomarkers discovered in the clinical settings
of early-stage diagnosis and among patients at high risk for lung cancer, will be examined.

Main Objective: The main objectives of this study are to a) discover new biomarkers in early stage
lung cancer for use in diagnosis of disease and b) discover new genomic and proteomic biomarkers
in the airway and blood for preclinical detection of lung cancer among people at high risk of
developing lung cancer.

Participants: Participants will be recruited to one of two cohorts for the DECAMP-2 study:
a) the cross-sectional cohort, Group A, which will comprise approximately 80 patients planned
to go to resection surgery due to recently-diagnosed early stage lung cancer or suspected
early stage lung cancer that requires surgery for definitive diagnosis, and b) the longitudinal
screening cohort, Group B, which will comprise approximately 800 people at high risk for lung
cancer based on smoking history and an additional confounding factor of chronic obstructive
pulmonary disease (COPD), emphysema, or at least one first-degree relative with a diagnosis
of lung cancer.

Study Design Summary: Each participant will undergo fiberoptic bronchoscopy, have blood
and urine collected, provide sputum and cellular samples, and complete questionnaires. The
imaging study leading to resection surgery for Group A participants will need to be submitted
to the American College of Radiology (ACR) Imaging Core Laboratory.  Imaging studies performed
per protocol in Group B participants will be submitted to the ACR imaging core lab, as well. Follow
up for Group A will be completed at the time of histopathologic diagnosis after resection surgery;
for Group B, annual follow up procedures are outlined in the protocol. Group B participants will
complete the study at four years, or at the time of lung cancer diagnosis (to allow for standard
practice treatment outside of the study parameters) with the additional requirement of a year-four
form describing treatment/response and vital status.