DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
NCT ID: NCT04165564
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
85 participants
OBSERVATIONAL
2020-08-24
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
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)
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)
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)
Biosamples of airway and blood
Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
Interventions
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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)
Biosamples of airway and blood
Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
46 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
American College of Radiology Imaging Network
NETWORK
Boston University
OTHER
Responsible Party
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Principal Investigators
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Ehab Billatos, MD
Role: PRINCIPAL_INVESTIGATOR
Boston University
Denise Aberle, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
George Washko, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
University of California Los Angeles
Los Angeles, California, United States
VA Greater LA Healthcare System
Los Angeles, California, United States
Naval Medical Center San Diego
San Diego, California, United States
University of Iowa
Iowa City, Iowa, United States
Walter Reed Army Medical Center
Bethesda, Maryland, United States
VA Boston Healthcare System
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
American College of Radiology [Administrative Site]
Philadelphia, Pennsylvania, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Brown University [Administrative Site]
Providence, Rhode Island, United States
VA Tennessee Valley Healthcare System
Nashville, Tennessee, United States
MD Anderson Cancer Center [Administrative Site]
Houston, Texas, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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H-39556
Identifier Type: -
Identifier Source: org_study_id
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