ACRIN Protocol 4704 | DECAMP-2

Principal Investigators

Ehab Billatos, MD, and Denise Aberle, MD

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 seven Veterans Administration hospitals (VAH), the four designated Military Treatment Facilities (MTF), and three academic hospitals as clinical study sites, as well as several molecular biomarker laboratories, along with biostatistics, bioinformatics, pathology and biorepository cores.

Overview

The DECAMP-2 trial was developed under the Department of Defense (DoD) and is funded through the DoD Lung Cancer Research Program (LCRP), National Cancer Institute (NCI), Janssen Pharmaceuticals, Inc., and Novartis Institutes for Biomedical Research. 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 noninvasive 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.

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 noninvasive 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.

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 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. Participant imaging studies performed per protocol will be submitted to the American College of Radiology imaging core lab. Annual follow-up procedures are outlined in the protocol. 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.