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DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

Sponsor
Boston University (Other)
Overall Status
Completed
CT.gov ID
NCT01785342
Collaborator
American College of Radiology Imaging Network (Other), National Cancer Institute (NCI) (NIH)
489
Enrollment
15
Locations
109.9
Actual Duration (Months)
32.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
489 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Feb 28, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Lung Cancer [2 years]

      Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regents of the University of California LA (Los Angeles VA Healthcare System) Los Angeles California United States 90073
    2 University of California Los Angeles Medical Center Los Angeles California United States 90095
    3 Naval Medical Center San Diego San Diego California United States 23708
    4 Denver Research Institute Denver Colorado United States 80220
    5 Walter Reed National Military Medical Center Bethesda Maryland United States 20814
    6 Boston University Medical Center Boston Massachusetts United States 02118
    7 Boston VA Research Institute, Inc Boston Massachusetts United States 02132
    8 Health Research Inc. Roswell Park Division Buffalo New York United States 14263
    9 Trustees of University of Pennsylvania (Philadelphia VA Medical Center) Philadelphia Pennsylvania United States 19104
    10 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    11 Veterans Research Foundation of Pittsburgh Pittsburgh Pennsylvania United States 15240
    12 Middle Tennessee Research Institute (Vanderbilt University) Nashville Tennessee United States 37212
    13 Dallas VA Research Corporation Dallas Texas United States 75216
    14 San Antonio Military Medical Center San Antonio Texas United States 78219
    15 Naval Medical Center Portsmouth Portsmouth Virginia United States 23708

    Sponsors and Collaborators

    • Boston University
    • American College of Radiology Imaging Network
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Ehab Billatos, MD, Boston University
    • Principal Investigator: Deni Aberle, MD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston University
    ClinicalTrials.gov Identifier:
    NCT01785342
    Other Study ID Numbers:
    • H-31755
    • U01CA196408
    First Posted:
    Feb 7, 2013
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Multiple Pulmonary Nodules

    Study Results

    No Results Posted as of Mar 15, 2022