ACRIN Protocol 4703 | DECAMP-1

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

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.

Data Forms


Site Memos


Imaging Materials


Biospecimen Procedures


Procedure Manual

Transmittal Forms

DECAMP Biospecimen Procedure Manual

Researchers interested in accessing DECAMP biospecimens should submit their responses to the questions in the DECAMP Biospecimen Access Request document to Maria T. Perez, PhD, DECAMP Scientific Program Manager (perezmt@bu.edu).

Education and Recruitment Materials


The ACR makes a variety of tools available to help site personnel with study participant enrollment. If your site would like to use any of the tools listed below, please contact the project specialist assigned to the trial.

Recruitment Manual

Recruitment of participants constitutes a significant portion of the workload associated with the DECAMP studies. Therefore, the DECAMP project at your site will operate more effectively and efficiently if you develop and implement a well-thought-out recruitment plan. The recruitment strategies presented in this manual are intended to serve as a framework as your site develops its individual plan. Download recruitment manual »

Participant Brochure

A DECAMP-1 (ACRIN 4703) brochure is available for participating sites to assist with participant enrollment. All participant recruitment materials must be approved by the site's IRB prior to distribution. A link to an electronic version for submission to the IRB is provided below. Download DECAMP-1 brochure »

Poster

A DECAMP-1 (ACRIN 4703) poster is available for display in areas likely to be seen by cardiac patients as well as in general high-traffic areas inside or outside your facility. Download DECAMP -1 poster »

Eligibility Card

Pocket-sized eligibility cards are available for distribution to clinicians who may assist with identifying potential participants. The card does not require IRB approval. Download eligibility card »

Participating Sites

California


VA Greater Los Angeles Health Care System

Investigators:
Steve Dubinett, MD
David Elashoff, PhD
Gina Lee, MD

Research Associate:
Babak Aryanfar
Babak.Aryanfar@va.gov

Enrollment Status: Open

Naval Medical Center San Diego

Investigator: CAPT J. Scott Parrish, MD

Research Associate:
Lindsey White
619-532-5478
lindsey.j.white3.ctr@mail.mil

Enrollment Status: Open

UCLA Medical Center, Los Angeles

Investigators:
Steve Dubinett, MD
David Elashoff, PhD
Gina Lee, MD

Research Associate:
Rafael Corona, LVN
RCorona@mednet.ucla.edu

Enrollment Status: Open
 
   

Colorado


VA Eastern Colorado Health Care System, Denver

Investigators:
Robert L. Keith, MD
Daniel Merrick, MD

Research Associate:
Brandi Kubala, MA, CCRP
303-724-1657
brandi.kubala@cuanschutz.edu

Enrollment Status: Open
   

Maryland


Walter Reed National Military Medical Center, Bethesda

Investigator: Robert Browning, MD

Research Associate:
Luis E. Rojas
301-295-8713
lrojas@hjfresearch.org

Enrollment Status: Open
   

Massachusetts


VA Boston Healthcare System, Roxbury

Investigators:
Ron Goldstein, MD
Eric Garshik, MD

Research Associate:
Kathleen Lacerda
857-203-6478
Kathleen.Lacerda@va.gov

Enrollment Status: Open

Boston University Medical Center

Investigator: Ehab Billatos, MD

Research Associate:
Denise Fine
617-638-8716
Denise.Fine@bmc.org

Enrollment Status: Open
   

Pennsylvania


Philadelphia VA Medical Center

Investigators:
Anil Vachani, MD
Daniel Sterman, MD
Andrew Haas, MD

Enrollment Status: Open

VA Pittsburgh Healthcare System

Investigator: Charles Atwood, MD

Research Associate:
Greg Owens
412-360-1527
Gregory.Owens@va.gov

Enrollment Status: Open

Hospital of the University of Pennsylvania, Philadelphia

Investigators:
Anil Vachani, MD
Daniel Sterman, MD
Andrew Haas, MD

Enrollment Status: Open
 
   

Tennessee


Nashville VA Medical Center

Investigator: Pierre Massion, MD

Research Associate:
Trey Helton
John.Helton2@va.gov

Enrollment Status: Open
 
   

Virginia


Naval Medical Center Portsmouth

Investigator: Evan Butlin, MD

Research Associate:
Holly LaPerriere, BS, CCRC
757-953-2087
holly.a.laperriere.ctr@mail.mil

Enrollment Status: Open
 

DECAMP Study Team Contact Information

ACRIN 4703 & 4704  Contact Phone  Email 
BU Scientific Program Manager  Maria Perez    perezmt@bu.edu
       
ACR Project Manager  Irene Mahon  215 574-3249  imahon@acr.org
       
ACR Data Management
 Jean Ly  215-574-3234  jly@acr.org
       
ACR Image Core Lab
 Joe Bauza
 Sarah Gevo
 215 940-8886
 215-574-3176
 jbauza@acr.org
 sgevo@acr.org
       
Regulatory-Monitoring
 Chris Steward  215 574-3787  csteward@acr.org
       
BU Biorepository Manager
 Jack Cunningham    jackcunn@bu.edu