DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and non-invasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease
• Intervention / Treatment: Other: Institutional standard of care; Other: Biosamples of airway and blood

Detailed Description

The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that previously initiated the DECAMP-1 and DECAMP-2 studies for lung cancer early detection. Now, with the support of Johnson and Johnson, 3 Veterans Administration Hospitals (VAH), 3 Military Treatment Facilities (MTF) and 12 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores, we are expanding our work in lung cancer early detection.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Ehab Billatos, MD; Phone Number: 617-358-7039; Email: ebillato@bu.edu
• Study Contact Backup: Name: Denise Fine, BS; Phone Number: 617-638-8716; Email: denise.fine@bmc.org

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama, Birmingham
      • Contact: Mark Dransfield, MD; Phone Number: 205-934-5425; Email: mdransfield@uabmc.edu
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
      • Contact: Ashley Prosper, MD
    • Los Angeles, California, United States, 90095
      • Recruiting
      • VA Greater LA Healthcare System
      • Contact: Steve Dubinett, MD; Phone Number: 310-267-2725; Email: sdubinett@mednet.ucla.edu
      • Contact: Gina Lee, MD; Email: gina.lee@va.gov
    • San Diego, California, United States, 92134
      • Recruiting
      • Naval Medical Center San Diego
      • Contact: John Scott Parrish, MD; Phone Number: 619-532-9067; Email: John.Parrish@med.navy.mil
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Rolando Sanchez; Phone Number: 319-353-8862; Email: rolando-sanchez@uiowa.edu
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Recruiting
      • Walter Reed Army Medical Center
      • Contact: Robert Browning, MD; Phone Number: 601-395-0196; Email: robert.f.browning2.civ@mail.mil
  • Massachusetts
    • Boston, Massachusetts, United States, 02110
      • Recruiting
      • VA Boston Healthcare System
      • Contact: Ronald Goldstein, MD; Phone Number: 617-638-4860; Email: ronald.goldstein@va.gov
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: MeiLan Han, MD; Phone Number: 734-615-9772; Email: mrking@med.umich.edu
      • Contact: Wassim Labaki, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Tobias Piekert, MD; Phone Number: 507-284-4162; Email: Peikert.Tobias@mayo.edu
      • Contact: David Midthun, MD; Email: midthun.david@mayo.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Peter Mazzone, MD; Phone Number: 216-445-4812; Email: mazzonp@ccf.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University
      • Contact: Gerard Criner, MD; Phone Number: 215-707-8113; Email: Gerard.Criner@tuhs.temple.edu
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania School of medicine
      • Contact: David M Dibardino, MD; Phone Number: 215-615-0359; Email: dibardino@mail.med.upenn.edu
    • Philadelphia, Pennsylvania, United States, 19103
      • Active, not recruiting
      • American College of Radiology [Administrative Site]
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: David Wilson, MD; Phone Number: 412-687-4295; Email: wilsondo@upmc.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Active, not recruiting
      • Brown University [Administrative Site]
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • VA Tennessee Valley Healthcare System
      • Contact: Pierre Massion, MD; Phone Number: 615-322-3000; Email: pierre.massion@Vanderbilt.Edu
  • Texas
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • MD Anderson Cancer Center [Administrative Site]
  • Virginia
    • Portsmouth, Virginia, United States, 23708
      • Recruiting
      • Naval Medical Center Portsmouth
      • Contact: Jacob Jonas Carmichael, MD; Phone Number: 757-953-5008; Email: jacob.j.carmichael.mil@mail.mil
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • West Virginia University
      • Contact: Ghulam Abbbas, MD; Phone Number: 304-598-4779; Email: ghulam.abbas@hsc.wvu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients are identified for inclusion in the study based on the observation of a lung nodule on screening or incidentally found by routine chest CT scans, between 0.8-2.5 cm diameter or observation of a mixed density nodule in which the solid portion is 0.6-2.5 cm diameter. These patients are managed according to institutional standard of care. This may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines)

Description

Inclusion Criteria:

• Radiologic diagnosis of solid indeterminate pulmonary nodule (0.8 to 2.5 cm) identified in the past 3 months OR semi-solid (mixed density) nodule with solid component of at least 0.6 cm identified in the past 12 months; must be of appropriate size at enrollment.
• CT scan completed within 3 months prior to enrollment
• 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 approximately three years from enrollment
• Able to complete the Patient Lung History questionnaire with study staff

Arm 1 - Screening

• Age 55-77 years old
• Current and former smokers with 30 pack-years or more(and quit less than 15 years ago)

Arm 2 - Incidental

• Age > 45 years old
• Current and former smokers with 10 pack-years or more(and quit less than 15 years ago)

Exclusion Criteria:

• History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (not including non-melanoma skin cancer)
• Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recent hemoptysis)
• Diagnosis of pure ground glass opacities for the target lesion on chest CT within the last 12 months (i.e., mixed features on the target lesion and pure ground glass opacity on non-target lesions are acceptable as mentioned above)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 - Screening; Participants in this group will be 55-77 years old and currently smoke or were former smokers with 30 pack-years or more (and quit less than 15 years ago)	Other: Institutional standard of care; Institutional standard of care may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines); Other: Biosamples of airway and blood; Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
Group 2 - Incidental; Participants in this group will be > 45 years old and currently smoke or were former smokers with 10 pack-years or more (and quit less than 15 years ago)	Other: Institutional standard of care; Institutional standard of care may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines); Other: Biosamples of airway and blood; Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of lung cancer	The number of new cases of lung cancer that developed divided by the population at risk.	3 years

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Johnson & Johnson; American College of Radiology Imaging Network
• Investigators: Principal Investigator: Ehab Billatos, MD, Boston University; Principal Investigator: Denise Aberle, MD, University of California, Los Angeles; Principal Investigator: George Washko, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2020
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Indeterminate pulmonary nodules; Molecular biomarkers for lung cancer diagnosis; Imaging for lung cancer diagnosis; High risk smokers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: H-39556

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