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

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ClinicalTrials.gov Identifier: NCT01785342
Recruitment Status : Recruiting
First Posted : February 7, 2013
Last Update Posted : October 30, 2018
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 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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


Contacts
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Contact: Avrum Spira, MD aspira@bu.edu
Contact: Elizabeth Moses, PhD 617-358-7092 emoses@bu.edu

Locations
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United States, California
Regents of the University of California LA (Los Angeles VA Healthcare System) Recruiting
Los Angeles, California, United States, 90073
Contact: Steven Dubinett, MD       SDubinett@mednet.ucla.edu   
Contact: Fran Rosen       frosen@mednet.ucla.edu   
Principal Investigator: Steven Dubinett, MD         
University of California Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Steve Dubinett, MD       SDubinett@mednet.ucla.edu   
Contact: Babak Aryanfar       Babak.Aryanfar@va.gov   
Principal Investigator: Steve Dubinett, MD         
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 23708
Contact: John S Parrish, MD       john.parrish@med.navy.mil   
Contact: Lindsey White       lwhite@acr.org   
Principal Investigator: John S Parrish, MD         
United States, Colorado
Denver Research Institute Recruiting
Denver, Colorado, United States, 80220
Contact: Robert Keith, MD       Robert.Keith@ucdenver.edu   
Contact: Mary Jackson       mary.k.jackson@ucdenver.edu   
Principal Investigator: Robert Keith, MD         
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20814
Contact: Robert Browning, MD       robert.browningjr@med.navy.mil   
Contact: Maggie Nellissery       mnellissery@acr.org   
Principal Investigator: Robert Browning, MD         
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Ehab Billatos, MD       ehab.billatos@bmc.org   
Contact: Denise Fine       Denise.Fine@bmc.org   
Principal Investigator: Ehab Billatos, MD         
Boston VA Research Institute, Inc Recruiting
Boston, Massachusetts, United States, 02132
Contact: Ronald Goldstein, MD       Ronald.Goldstein@va.gov   
Contact: Kathleen LaCerda       kathleen.lacerda@va.gov   
Principal Investigator: Ronald Goldstein, MD         
United States, New York
Health Research Inc. Roswell Park Division Recruiting
Buffalo, New York, United States, 14263
Contact: Mary Reid, PhD       Mary.Reid@roswellpark.org   
Contact: Noelle Brunsing       Noelle.Brunsing@RoswellPark.org   
Principal Investigator: Mary Reid, PhD         
United States, Pennsylvania
Trustees of University of Pennsylvania (Philadelphia VA Medical Center) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Anil Vachani, MD       avachani@mail.med.upenn.edu   
Contact: Kristina Maletteri       kdmaletteri@gmail.com   
Principal Investigator: Anil Vachani         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Anil Vachani, MD       avachani@mail.med.upenn.edu   
Principal Investigator: Anil Vachani, MD         
Veterans Research Foundation of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Charles Atwood, MD       atwoodcw@upmc.edu   
Contact: Greg Owens       Gregory.Owens@va.gov   
Principal Investigator: Charles Atwood, MD         
United States, Tennessee
Middle Tennessee Research Institute (Vanderbilt University) Recruiting
Nashville, Tennessee, United States, 37212
Contact: Pierre Massion, MD       pierre.massion@vanderbilt.edu   
Contact: Trey Helton       John.Helton2@va.gov   
Principal Investigator: Pierre Massion, MD         
United States, Texas
Dallas VA Research Corporation Recruiting
Dallas, Texas, United States, 75216
Contact: John Battaile, MD       JohnT.Battaile@va.gov   
Contact: Mitchell Kroll       Mitchell.Kroll@va.gov   
Principal Investigator: John Battaile, MD         
San Antonio Military Medical Center Completed
San Antonio, Texas, United States, 78219
United States, Virginia
Naval Medical Center Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708
Contact: Jonas Carmichael, MD       jacob.j.carmichael.mil@mail.mil   
Contact: Holly LaPerriere       holly.a.laperriere.ctr@mail.mil   
Principal Investigator: Jonas Carmichael, MD         
Principal Investigator: Christopher Kuzniewski, MD         
Sponsors and Collaborators
Boston University
American College of Radiology Imaging Network
Investigators
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Principal Investigator: Avrum Spira, MD Boston University
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     History of Changes
Other Study ID Numbers: H-31755
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
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