ACRIN Protocol 4703 | DECAMP-1

Principal Investigators

Ehab Billatos, MD, and Denise Aberle, MD

Status

Closed to accrual; in follow-up

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-1 trial was developed under the Department of Defense (DoD) and funded through the DoD Lung Cancer Research Program (LCRP), National Cancer Institute (NCI) and Janssen Pharmaceuticals, Inc. 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 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.

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.