DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer

NCT02504697 | Active Not Recruiting DMC

• 1 other identifier: H-32479
• Study Type: observational
• Target: 665
• Locations: 1 country
• Sites: 15

Brief 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. 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.

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Lung Cancer

  Four years

Study Arms (1)

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.

Other: Biosamples from airway and blood

Interventions

Biosamples from airway and blood OTHER

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

Longitudinal Cohort

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Military personnel

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• American College of Radiology Imaging Network: collaborator

Study Sites (15)

Regents of the University of California LA (Los Angeles VA Healthcare System)

Los Angeles, California, 90073, United States

Location

University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Denver Research Institute

Denver, Colorado, 80220, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Boston VA Research Institute, Inc

Boston, Massachusetts, 02132, United States

Location

Health Research Inc. Roswell Park Division

Buffalo, New York, 14263, United States

Location

Trustees of University of Pennsylvania (Philadelphia VA Medical Center)

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Veterans Research Foundation of Pittsburgh

Pittsburgh, Pennsylvania, 14520, United States

Location

Middle Tennessee Research Institute (Vanderbilt University)

Nashville, Tennessee, 37212, United States

Location

Dallas VA Research Corporation

Dallas, Texas, 75216, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78219, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

Related Publications (2)

• 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.

  PMID: 32946850 DERIVED

• Billatos 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.

  PMID: 30845938 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, Sputum, Nasal brushing, Buccal scraping, Bronchial Biopsy, Bronchial brushing, lung tissue

MeSH Terms

Conditions

Lung Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ehab Billatos, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Denise Aberle, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: July 22, 2015
• Study Start: September 1, 2011
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (15)