DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

NCT ID: NCT04165564

Last Updated: 2025-04-30

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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)

Intervention Type OTHER

Biosamples of airway and blood

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

Intervention Type OTHER

Eligibility Criteria

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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

* 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)
Minimum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

American College of Radiology Imaging Network

NETWORK

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

VA Greater LA Healthcare System

Los Angeles, California, United States

Site Status

Naval Medical Center San Diego

San Diego, California, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Walter Reed Army Medical Center

Bethesda, Maryland, United States

Site Status

VA Boston Healthcare System

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

American College of Radiology [Administrative Site]

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Brown University [Administrative Site]

Providence, Rhode Island, United States

Site Status

VA Tennessee Valley Healthcare System

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center [Administrative Site]

Houston, Texas, United States

Site Status

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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H-39556

Identifier Type: -

Identifier Source: org_study_id

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