Lung CancerDECAMP-1NCT01785342
DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules
An observational study of Lung Cancer, run by Boston University at 15 sites in United States.
Trial summary
The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Biosample and Imaging Collection
- How many people
- 489 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2013to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Military personnel
Who may be able to join
- 45 years of age or older;
- Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);
- Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked)
- 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 minimum of two years;
- Able to fill out Patient Lung History questionnaire;
- Willing and able to provide a written informed consent.
Who cannot join
- History or previous diagnosis of lung cancer;
- Diagnosis of pure ground glass opacities on chest CT;
- Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness;
- Allergies to any local anesthetic that may be used to obtain biosamples in the study.
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, 20814
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, 15240
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
San Antonio Military Medical Center
San Antonio, Texas, 78219
Naval Medical Center San Diego
San Diego, California, 23708
About this study
Official title: Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules
The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.
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 goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging \& molecular markers) that results in the most robust diagnostic predictor will be evaluated.
- Conditions
- Lung Cancer
- Being tested
- Biosample and Imaging Collection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosample and Imaging CollectionOther
Also called Blood,, Urine,, Buccal Scraping,, Nasal,
Collection of listed biosamples and CT imaging.
| Study group | Role | What they receive |
|---|---|---|
| Indeterminate Pulmonary Nodule | The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. Biosample and imaging collection will be done. Receives: Other: Biosample and Imaging Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer
Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Radiology Imaging Network, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ehab Billatos, MD, Principal investigator, Boston UniversityDeni Aberle, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785342
- Sponsor's protocol ID
- H-31755
- Other IDs
- U01CA196408
- Acronym
- DECAMP-1
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2013
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kinsey CM, Billatos E, Mori V, Tonelli B, Cole BF, Duan F, Marques H, de la Bruere I, Onieva J, San Jose Estepar R, Cleveland A, Idelkope D, Stevenson C, Bates JHT, Aberle D, Spira A, Washko G, San Jose Estepar R. A simple assessment of lung nodule location for reduction in unnecessary invasive procedures. J Thorac Dis. 2021 Jul;13(7):4207-4216. doi: 10.21037/jtd-20-3093.
PubMed 34422349Billatos 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 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT01785342
- Acronym / sponsor ID
- DECAMP-1 / H-31755
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- American College of Radiology Imaging Network, National Cancer Institute (NCI)
- Study start
- Jan 2013 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 7 Feb 2013 (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 is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.
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 goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging \& molecular markers) that results in the most robust diagnostic predictor will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indeterminate Pulmonary Nodule | – | Other: Biosample and Imaging CollectionThe goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. Biosample and imaging collection will be done. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Military personnel
Key inclusion criteria (8 listed)
- 45 years of age or older;
- Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);
- Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked)
- Willing to undergo fiberoptic bronchoscopy;
- Able to tolerate all biospecimen collection as required by protocol;
Key exclusion criteria (4 listed)
- History or previous diagnosis of lung cancer;
- Diagnosis of pure ground glass opacities on chest CT;
- Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness;
- Allergies to any local anesthetic that may be used to obtain biosamples in the study.
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 |
|---|---|---|
| Biosample and Imaging CollectionAlso: Blood,, Urine,, Buccal Scraping,, Nasal,Collection of listed biosamples and CT imaging. | Other | Indeterminate Pulmonary Nodule |
Primary outcome
Lung Cancer
Time frame: 2 years
Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 34422349Kinsey CM, Billatos E, Mori V, Tonelli B, Cole BF, Duan F, Marques H, de la Bruere I, Onieva J, San Jose Estepar R, Cleveland A, Idelkope D, Stevenson C, Bates JHT, Aberle D, Spira A, Washko G, San Jose Estepar R. A simple assessment of lung nodule location for reduction in unnecessary invasive procedures. J Thorac Dis. 2021 Jul;13(7):4207-4216. doi: 10.21037/jtd-20-3093.
- 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
Deni 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 Lung Cancer, 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: finished, as of the sponsor's last update on 15 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 2 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 NCT01785342, which also lists 3 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 15 Mar 2022.