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Active, not recruitingNCT04165564Updated Apr 1, 2026

DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

An observational study in Pulmonary Disease, sponsored by Boston University. Active, not recruiting at 19 sites in United States. Open to participants aged 46 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Boston University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
46 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Pulmonary Disease

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Keywords

  • Indeterminate pulmonary nodules
  • Molecular biomarkers for lung cancer diagnosis
  • Imaging for lung cancer diagnosis
  • High risk smokers
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 85 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
46 Years and older
Sexes eligible
All
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)

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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 · Other: Biosamples of airway and blood

  • 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 · Other: Biosamples of airway and blood

Interventions

  • OtherInstitutional 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)

  • OtherBiosamples of airway and blood

    Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.

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What researchers measure

Primary outcomes

  1. Incidence of lung cancer

    The number of new cases of lung cancer that developed divided by the population at risk.

    Time frame: 3 years

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Study locations

19 sites
  • University of Alabama, Birmingham
    Birmingham, Alabama 35233, United States
  • University of California Los Angeles
    Los Angeles, California 90095, United States
  • VA Greater LA Healthcare System
    Los Angeles, California 90095, United States
  • Naval Medical Center San Diego
    San Diego, California 92134, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • Walter Reed Army Medical Center
    Bethesda, Maryland 20889, United States
  • VA Boston Healthcare System
    Boston, Massachusetts 02110, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • American College of Radiology [Administrative Site]
    Philadelphia, Pennsylvania 19103, United States
  • University of Pennsylvania School of Medicine
    Philadelphia, Pennsylvania 19104, United States
  • Temple University
    Philadelphia, Pennsylvania 19140, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15232, United States
  • Brown University [Administrative Site]
    Providence, Rhode Island 02912, United States
  • VA Tennessee Valley Healthcare System
    Nashville, Tennessee 37232, United States
  • MD Anderson Cancer Center [Administrative Site]
    Houston, Texas 77030, United States
  • Naval Medical Center Portsmouth
    Portsmouth, Virginia 23708, United States
  • West Virginia University
    Morgantown, West Virginia 26505, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04165564
Lead sponsor
Boston University
Collaborators
Johnson & Johnson, American College of Radiology Imaging Network
Responsible party
Sponsor
First posted
Nov 18, 2019
Start date
Aug 24, 2020
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 1, 2026

Study contacts

Ehab Billatos, MD
principal investigator · Boston University
Denise Aberle, MD
principal investigator · University of California, Los Angeles
George Washko, MD
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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