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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785342
Recruitment Status : Suspended (Currently suspended due to Covid-19 policies.)
First Posted : February 7, 2013
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
American College of Radiology Imaging Network
Information provided by (Responsible Party):
Boston University

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
Lung Cancer 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.

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Study Type : Observational
Estimated Enrollment : 500 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 : January 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Lung Cancer [ Time Frame: 2 years ]
    Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.


Biospecimen Retention:   Samples With DNA
Blood, Urine, Sputum, Nasal brushing, Buccal scraping, Bronchial Biopsy, Bronchial brushing, lung tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Military personnel
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785342


Locations
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United States, California
Regents of the University of California LA (Los Angeles VA Healthcare System)
Los Angeles, California, United States, 90073
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
Naval Medical Center San Diego
San Diego, California, United States, 23708
United States, Colorado
Denver Research Institute
Denver, Colorado, United States, 80220
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Boston VA Research Institute, Inc
Boston, Massachusetts, United States, 02132
United States, New York
Health Research Inc. Roswell Park Division
Buffalo, New York, United States, 14263
United States, Pennsylvania
Trustees of University of Pennsylvania (Philadelphia VA Medical Center)
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Veterans Research Foundation of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
United States, Tennessee
Middle Tennessee Research Institute (Vanderbilt University)
Nashville, Tennessee, United States, 37212
United States, Texas
Dallas VA Research Corporation
Dallas, Texas, United States, 75216
San Antonio Military Medical Center
San Antonio, Texas, United States, 78219
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States, 23708
Sponsors and Collaborators
Boston University
American College of Radiology Imaging Network
Investigators
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Principal Investigator: Ehab Billatos, MD Boston University
Principal Investigator: Deni Aberle, MD University of California, Los Angeles
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01785342    
Other Study ID Numbers: H-31755
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Multiple Pulmonary Nodules
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases