DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

March 27, 2026 updated by: Boston University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ehab Billatos, MD
  • Phone Number: 617-358-7039
  • Email: ebillato@bu.edu

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years and older (Adult, Older Adult)

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Institutional standard of care may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines)
Other: 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)
Other: 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)
Other: Biosamples of airway and blood
Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of lung cancer
Time Frame: 3 years
The number of new cases of lung cancer that developed divided by the population at risk.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johnson & Johnson
American College of Radiology Imaging Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ehab Billatos, MD, Boston University
  • Principal Investigator: Denise Aberle, MD, University of California, Los Angeles
  • Principal Investigator: George Washko, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-39556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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