Clinical trial NCT01785342: DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules
Official title: Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: American College of Radiology Imaging Network
name: National Cancer Institute (NCI)
First posted: 2013-02-07
Enrollment: 489
Sex: ALL
Minimum age (years): 45
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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Lung Cancer
timeFrame: 2 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: Deni Aberle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.