Pulmonary DiseaseNCT04165564
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
An observational study of Pulmonary Disease, run by Boston University at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Biosamples of airway and blood
- How many people
- 85 participants
- Where
- 19 sitesUnited States
- Study dates
- 24 Aug 2020to Dec 2026
- 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 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
University of Michigan
Ann Arbor, Michigan, 48109
Walter Reed Army Medical Center
Bethesda, Maryland, 20889
University of Alabama, Birmingham
Birmingham, Alabama, 35233
VA Boston Healthcare System
Boston, Massachusetts, 02110
Cleveland Clinic
Cleveland, Ohio, 44195
MD Anderson Cancer Center [Administrative Site]
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of California Los Angeles
Los Angeles, California, 90095
VA Greater LA Healthcare System
Los Angeles, California, 90095
West Virginia University
Morgantown, West Virginia, 26505
VA Tennessee Valley Healthcare System
Nashville, Tennessee, 37232
American College of Radiology [Administrative Site]
Philadelphia, Pennsylvania, 19103
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Brown University [Administrative Site]
Providence, Rhode Island, 02912
Mayo Clinic
Rochester, Minnesota, 55905
Naval Medical Center San Diego
San Diego, California, 92134
About this study
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.
- Conditions
- Pulmonary Disease
- Being tested
- Institutional standard of care, Biosamples of airway and blood
- Keywords
- Indeterminate pulmonary nodules, Molecular biomarkers for lung cancer diagnosis, Imaging for lung cancer diagnosis, High risk smokers
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Institutional standard of careOther
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 bloodOther
Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Institutional standard of care; Other: Biosamples of airway and blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of lung cancer
The number of new cases of lung cancer that developed divided by the population at risk.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start24 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, 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 AngelesGeorge Washko, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165564
- Sponsor's protocol ID
- H-39556
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2019
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers
- ClinicalTrials.gov ID
- NCT04165564
- Acronym / sponsor ID
- H-39556
- Conditions
- Pulmonary Disease
- Keywords
- Indeterminate pulmonary nodules, Molecular biomarkers for lung cancer diagnosis, Imaging for lung cancer diagnosis, High risk smokers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Johnson & Johnson, American College of Radiology Imaging Network
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 2019 (actual)
- 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Screening | – | Other: Institutional standard of care, Other: Biosamples of airway and bloodParticipants 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) |
| Group 2 - Incidental | – | Other: Institutional standard of care, Other: Biosamples of airway and bloodParticipants 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) |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Institutional standard of careInstitutional standard of care may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines) | Other | Group 1 - Screening, Group 2 - Incidental |
| Biosamples of airway and bloodIdentify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer. | Other | Group 1 - Screening, Group 2 - Incidental |
Primary outcome
Incidence of lung cancer
Time frame: 3 years
The number of new cases of lung cancer that developed divided by the population at risk.
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.
- 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
George Washko, MD principal investigator
Brigham and Women's Hospital
19 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 19 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 11 inclusion and 3 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 19 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?
Incidence of lung cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.