DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules (DECAMP-1)

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

The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Biosample and Imaging Collection

Detailed Description

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 4 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores. The DECAMP Coordinating Center will facilitate rapid selection, design and execution of clinical studies within this multi-institutional consortium. The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging & molecular markers) that results in the most robust diagnostic predictor will be evaluated.

• Study Type: Observational
• Enrollment (Actual): 489

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles Medical Center
    • Los Angeles, California, United States, 90073
      • Regents of the University of California LA (Los Angeles VA Healthcare System)
    • San Diego, California, United States, 23708
      • Naval Medical Center San Diego
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver Research Institute
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Walter Reed National Military Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
    • Boston, Massachusetts, United States, 02132
      • Boston VA Research Institute, Inc
  • New York
    • Buffalo, New York, United States, 14263
      • Health Research Inc. Roswell Park Division
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • UNIVERSITY of PENNSYLVANIA
    • Philadelphia, Pennsylvania, United States, 19104
      • Trustees of University of Pennsylvania (Philadelphia VA Medical Center)
    • Pittsburgh, Pennsylvania, United States, 15240
      • Veterans Research Foundation of Pittsburgh
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Middle Tennessee Research Institute (Vanderbilt University)
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Research Corporation
    • San Antonio, Texas, United States, 78219
      • San Antonio Military Medical Center
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Naval Medical Center Portsmouth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Military personnel

Description

Inclusion Criteria:

• 45 years of age or older;
• Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);
• Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked)
• Willing to undergo fiberoptic bronchoscopy;
• Able to tolerate all biospecimen collection as required by protocol;
• Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for a minimum of two years;
• Able to fill out Patient Lung History questionnaire;
• Willing and able to provide a written informed consent.

Exclusion Criteria:

• History or previous diagnosis of lung cancer;
• Diagnosis of pure ground glass opacities on chest CT;
• Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness;
• Allergies to any local anesthetic that may be used to obtain biosamples in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Indeterminate Pulmonary Nodule; The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. Biosample and imaging collection will be done.	Other: Biosample and Imaging Collection; Collection of listed biosamples and CT imaging.; Other Names: Blood,; Urine,; Buccal Scraping,; Nasal,; Bronchial Brushing,; Bronchial Biopsy,; Lung Tissue,; Sputum,; CT Imaging of Chest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Cancer	Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.	2 years

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Cancer Institute (NCI); American College of Radiology Imaging Network
• Investigators: Principal Investigator: Ehab Billatos, MD, Boston University; Principal Investigator: Deni Aberle, MD, University of California, Los Angeles

Publications and helpful links

General Publications

• Billatos E, Ash SY, Duan F, Xu K, Romanoff J, Marques H, Moses E, Han MK, Regan EA, Bowler RP, Mason SE, Doyle TJ, San Jose Estepar R, Rosas IO, Ross JC, Xiao X, Liu H, Liu G, Sukumar G, Wilkerson M, Dalgard C, Stevenson C, Whitney D, Aberle D, Spira A, San Jose Estepar R, Lenburg ME, Washko GR; DECAMP and COPDGene Investigators. Distinguishing Smoking-Related Lung Disease Phenotypes Via Imaging and Molecular Features. Chest. 2021 Feb;159(2):549-563. doi: 10.1016/j.chest.2020.08.2115. Epub 2020 Sep 16.
• Billatos E, Duan F, Moses E, Marques H, Mahon I, Dymond L, Apgar C, Aberle D, Washko G, Spira A; DECAMP investigators. Detection of early lung cancer among military personnel (DECAMP) consortium: study protocols. BMC Pulm Med. 2019 Mar 7;19(1):59. doi: 10.1186/s12890-019-0825-7.
• Kinsey CM, Billatos E, Mori V, Tonelli B, Cole BF, Duan F, Marques H, de la Bruere I, Onieva J, San Jose Estepar R, Cleveland A, Idelkope D, Stevenson C, Bates JHT, Aberle D, Spira A, Washko G, San Jose Estepar R. A simple assessment of lung nodule location for reduction in unnecessary invasive procedures. J Thorac Dis. 2021 Jul;13(7):4207-4216. doi: 10.21037/jtd-20-3093.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: H-31755; U01CA196408 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No