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

NCT ID: NCT02504697

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 665 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Biosamples from airway and blood

Intervention Type: OTHER

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

Interventions

Biosamples from airway and blood

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American College of Radiology Imaging Network

NETWORK

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ehab Billatos, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Denise Aberle, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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

Los Angeles, California, United States

University of California Los Angeles Medical Center

Los Angeles, California, United States

Naval Medical Center San Diego

San Diego, California, United States

Denver Research Institute

Denver, Colorado, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Boston University Medical Center

Boston, Massachusetts, United States

Boston VA Research Institute, Inc

Boston, Massachusetts, United States

Health Research Inc. Roswell Park Division

Buffalo, New York, United States

Trustees of University of Pennsylvania (Philadelphia VA Medical Center)

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Veterans Research Foundation of Pittsburgh

Pittsburgh, Pennsylvania, United States

Middle Tennessee Research Institute (Vanderbilt University)

Nashville, Tennessee, United States

Dallas VA Research Corporation

Dallas, Texas, United States

San Antonio Military Medical Center

San Antonio, Texas, United States

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32946850 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30845938 (View on PubMed)

Other Identifiers

H-32479

Identifier Type: -

Identifier Source: org_study_id