Clinical trial NCT02504697: DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Disease
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: American College of Radiology Imaging Network
First posted: 2015-07-22
Enrollment: 665
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Military personnel

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.

Eligibility criteria: Inclusion Criteria for longitudinal screening cohort

* 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.

Primary outcomes:
measure: Lung Cancer
timeFrame: Four years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Regents of the University of California LA (Los Angeles VA Healthcare System)
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles Medical Center
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Denver
country: United States
facility: Denver Research Institute
state: Colorado
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston VA Research Institute, Inc
state: Massachusetts
city: Buffalo
country: United States
facility: Health Research Inc. Roswell Park Division
state: New York
city: Philadelphia
country: United States
facility: Trustees of University of Pennsylvania (Philadelphia VA Medical Center)
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Veterans Research Foundation of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Middle Tennessee Research Institute (Vanderbilt University)
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Research Corporation
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
affiliation: Boston University
name: Ehab Billatos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Denise Aberle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.