Pulmonary DiseaseDECAMP-2NCT02504697
DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
An observational study of Pulmonary Disease, run by Boston University at 15 sites in United States.
Trial summary
The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and non-invasive biospecimens. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Biosamples from airway and blood
- How many people
- 665 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2011to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Military personnel
Who may be able to join
- Ages 50 to 79 years;
- Smoking status: Current or former smoker (≥10 cigarettes/day for current smokers, or ≥20 pack years for former smoker who quit 20 years ago or less)
- History of Chronic Obstructive Pulmonary Disease (COPD), emphysema, or at least one first-degree relative with a diagnosis of lung cancer;
- 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 maximum of four years or until diagnosis of lung cancer;
- Able to fill out Patient Lung History questionnaire;
- Willing and able to provide a written informed consent.
Who cannot join
- Diagnosis of lung cancer prior to the current assessment (that is, patients are eligible if first lung cancer diagnosis has been recently confirmed by bronchoscopic biopsy and is leading to resection surgery, but not if this is not a first diagnosis);
- Contraindications to nasal brushing or fiberoptic bronchoscopy, including: ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease (i.e., disease severity does not allow for bronchoscopic procedures), unstable cardiac or pulmonary disease, as well as other comorbidities leading to inability to protect airway, or altered level of consciousness;
- Allergies to any local anesthetic that may be used to obtain biosamples in the study;
- Weight greater than that allowable by the CT scanner.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Boston University Medical Center
Boston, Massachusetts, 02118
Boston VA Research Institute, Inc
Boston, Massachusetts, 02132
Health Research Inc. Roswell Park Division
Buffalo, New York, 14263
Dallas VA Research Corporation
Dallas, Texas, 75216
Denver Research Institute
Denver, Colorado, 80220
Regents of the University of California LA (Los Angeles VA Healthcare System)
Los Angeles, California, 90073
University of California Los Angeles Medical Center
Los Angeles, California, 90095
Middle Tennessee Research Institute (Vanderbilt University)
Nashville, Tennessee, 37212
Trustees of University of Pennsylvania (Philadelphia VA Medical Center)
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Veterans Research Foundation of Pittsburgh
Pittsburgh, Pennsylvania, 14520
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
San Antonio Military Medical Center
San Antonio, Texas, 78219
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Detection of Early Lung Cancer Among Military Personnel Study 2 (DECAMP-2): Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and non-invasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.
Read the 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 ACRIN 4704 study will recruit one cohort to achieve the aims of this study: a longitudinal screening cohort.
- Conditions
- Pulmonary Disease
- Being tested
- Biosamples from airway and blood
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosamples from airway and bloodOther
Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal Cohort | For this longitudinal screening cohort, we will enroll 800 participants who currently or historically smoked and who have a 10 year Bach risk model of lung cancer > 2.5% (5). We will include participants 50 to 79 years old, with ≥10 cigarettes/day for current smokers, or ≥20 pack years for former smoker who quit 20 years ago or less. In order to further enrich for lung cancer risk, participants also will have COPD/emphysema or at least one first-degree relative with a diagnosis of lung cancer. We will exclude patients previously diagnosed with lung cancer. These patients will be followed for a total of 4 years with annual follow-up visits. Biosamples from airway and blood and images will be collected. Receives: Other: Biosamples from airway and blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startSep 2011
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Radiology Imaging Network
- Responsible party
- Sponsor
- Investigators
- Ehab Billatos, MD, Principal investigator, Boston UniversityDenise Aberle, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504697
- Sponsor's protocol ID
- H-32479
- Acronym
- DECAMP-2
- Status last verified
- Mar 2026
- First submitted
- 27 May 2014
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Billatos E, Ash SY, Duan F, Xu K, Romanoff J, Marques H, Moses E, Han MK, Regan EA, Bowler RP, Mason SE, Doyle TJ, San Jose Estepar R, Rosas IO, Ross JC, Xiao X, Liu H, Liu G, Sukumar G, Wilkerson M, Dalgard C, Stevenson C, Whitney D, Aberle D, Spira A, San Jose Estepar R, Lenburg ME, Washko GR; DECAMP and COPDGene Investigators. Distinguishing Smoking-Related Lung Disease Phenotypes Via Imaging and Molecular Features. Chest. 2021 Feb;159(2):549-563. doi: 10.1016/j.chest.2020.08.2115. Epub 2020 Sep 16.
PubMed 32946850Billatos E, Duan F, Moses E, Marques H, Mahon I, Dymond L, Apgar C, Aberle D, Washko G, Spira A; DECAMP investigators. Detection of early lung cancer among military personnel (DECAMP) consortium: study protocols. BMC Pulm Med. 2019 Mar 7;19(1):59. doi: 10.1186/s12890-019-0825-7.
PubMed 30845938
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early Lung Cancer Among Military Personnel Study 2 (DECAMP-2): Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
- ClinicalTrials.gov ID
- NCT02504697
- Acronym / sponsor ID
- DECAMP-2 / H-32479
- Conditions
- Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- American College of Radiology Imaging Network
- Study start
- Sep 2011 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to improve lung cancer screening in high-risk individuals by identifying biomarkers of preclinical disease and disease risk that are measured in minimally invasive and non-invasive biospecimens. Existing biomarkers for lung cancer diagnosis as well as new biomarkers discovered specifically in this clinical setting will be examined. Biomarkers that identify individuals at highest risk for being diagnosed with lung cancer prior to the appearance of concerning symptoms could increase the utility of lung cancer surveillance and the efficiency of lung cancer chemoprevention clinical trials. Achieving these goals would improve the detection and treatment of early stage and incipient lung cancer, while restricting the risk of these procedures to those individuals who currently exhibit the early molecular warning signs of impending disease.
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 ACRIN 4704 study will recruit one cohort to achieve the aims of this study: a longitudinal screening cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Cohort | – | Other: Biosamples from airway and bloodFor this longitudinal screening cohort, we will enroll 800 participants who currently or historically smoked and who have a 10 year Bach risk model of lung cancer > 2.5% (5). We will include participants 50 to 79 years old, with ≥10 cigarettes/day for current smokers, or ≥20 pack years for former smoker who quit 20 years ago or less. In order to further enrich for lung cancer risk, participants also will have COPD/emphysema or at least one first-degree relative with a diagnosis of lung cancer. We will exclude patients previously diagnosed with lung cancer. These patients will be followed for a total of 4 years with annual follow-up visits. Biosamples from airway and blood and images will be collected. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Military personnel
Key inclusion criteria (8 listed)
- Ages 50 to 79 years;
- Smoking status: Current or former smoker (≥10 cigarettes/day for current smokers, or ≥20 pack years for former smoker who quit 20 years ago or less)
- History of Chronic Obstructive Pulmonary Disease (COPD), emphysema, or at least one first-degree relative with a diagnosis of lung cancer;
- Willing to undergo fiberoptic bronchoscopy;
- Able to tolerate all biospecimen collection as required by protocol;
Key exclusion criteria (4 listed)
- Diagnosis of lung cancer prior to the current assessment (that is, patients are eligible if first lung cancer diagnosis has been recently confirmed by bronchoscopic biopsy and is leading to resection surgery, but not if this is not a first diagnosis);
- Contraindications to nasal brushing or fiberoptic bronchoscopy, including: ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease (i.e., disease severity does not allow for bronchoscopic procedures), unstable cardiac or pulmonary disease, as well as other comorbidities leading to inability to protect airway, or altered level of consciousness;
- Allergies to any local anesthetic that may be used to obtain biosamples in the study;
- Weight greater than that allowable by the CT scanner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biosamples from airway and bloodIdentify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer. | Other | Longitudinal Cohort |
Primary outcome
Lung Cancer
Time frame: Four years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 32946850Billatos E, Ash SY, Duan F, Xu K, Romanoff J, Marques H, Moses E, Han MK, Regan EA, Bowler RP, Mason SE, Doyle TJ, San Jose Estepar R, Rosas IO, Ross JC, Xiao X, Liu H, Liu G, Sukumar G, Wilkerson M, Dalgard C, Stevenson C, Whitney D, Aberle D, Spira A, San Jose Estepar R, Lenburg ME, Washko GR; DECAMP and COPDGene Investigators. Distinguishing Smoking-Related Lung Disease Phenotypes Via Imaging and Molecular Features. Chest. 2021 Feb;159(2):549-563. doi: 10.1016/j.chest.2020.08.2115. Epub 2020 Sep 16.
- Derived from this study: PubMed 30845938Billatos E, Duan F, Moses E, Marques H, Mahon I, Dymond L, Apgar C, Aberle D, Washko G, Spira A; DECAMP investigators. Detection of early lung cancer among military personnel (DECAMP) consortium: study protocols. BMC Pulm Med. 2019 Mar 7;19(1):59. doi: 10.1186/s12890-019-0825-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehab Billatos, MD principal investigator
Boston University
Denise Aberle, MD principal investigator
University of California, Los Angeles
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, run by Boston University at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Cancer (time frame: Four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02504697, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.