Detection of early lung cancer among military personnel (DECAMP) consortium: study protocols

On Behalf Of The Decamp Investigators ,Ehab Billatos,Avrum Spira,Irene Mahon,Helga Marques,Fenghai Duan,George Washko,Elizabeth Moses,Lindsey Dymond,Charles Apgar,Denise Aberle

doi:10.1186/s12890-019-0825-7

On Behalf Of The Decamp Investigators , Ehab Billatos + Show 9 more

Open Access

https://doi.org/10.1186/s12890-019-0825-7

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Abstract

BackgroundLung cancer is the leading cause of cancer-related death due in large part to our inability to diagnose it at an early and potentially curable stage. Screening for lung cancer via low dose computed tomographic (LDCT) imaging has been demonstrated to improve mortality but also results in a high rate of false positive tests. The identification and application of non-invasive molecular biomarkers that improve the performance of CT imaging for the detection of lung cancer in high risk individuals would aid in clinical decision-making, eliminate the need for unnecessary LDCT follow-up, and further refine the screening criteria for an already large high-risk population.MethodsThe Detection of Early Lung Cancer Among Military Personnel (DECAMP) consortium is conducting two multicenter prospective studies with the goals of developing an integrated panel of both airway and blood-based molecular biomarkers that discriminate benign and malignant indeterminate nodules detected on CT scan as well as predict the future development of lung cancer in high-risk individuals. To achieve these goals, DECAMP is compiling an extensive array of biospecimens including nasal brushings, serum, plasma and intrathoracic airway samples (bronchial brushings and bronchial biopsies) from normal-appearing airway epithelium.DiscussionThis bank of samples is the foundation for multiple DECAMP efforts focused on the identification of those at greatest risk of developing lung cancer as well as the discrimination of benign and malignant pulmonary nodules. The clinical, imaging and biospecimen repositories will serve as a resource for the biomedical community and their investigation of the molecular basis of chronic respiratory disease.Trial registrationRetrospectively registered as NCT01785342 - DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules (DECAMP-1). Date of Registration: February 7, 2013.Retrospectively registered as NCT02504697 - DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer (DECAMP-2). Date of Registration: July 22, 2015.

Highlights

Lung cancer is the leading cause of cancer-related death due in large part to our inability to diagnose it at an early and potentially curable stage
DECAMP is a consortium of multi-disciplinary investigators recruiting cohorts of study subjects to develop and validate molecular and imaging-based biomarkers for early lung cancer detection
DECAMP-1 will identify biomarkers that can be used to discriminate the etiology of indeterminate pulmonary nodules and DECAMP-2 will identify smokers at greatest risk for future lung cancer

Summary

Methods

Study design DECAMP is a multi-center consortium comprised of 15 military treatment facilities, Veterans Affairs (VA) hospitals, and academic centers across the United States (Tables 1 and 2). In DECAMP-1, these subjects are subsequently followed per routine standard of care for their indeterminate pulmonary nodule until they achieve a final diagnosis of cancer or no cancer (up to 2 years). Clinical data is collected yearly for the full time of enrollment Those individuals diagnosed with lung cancer are followed for an additional 3 years to monitor treatment strategies and progression. Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for approximately 2 years from enrollment. Able to comply with standard-of-care follow-up visits, including clinical exams, diagnostic work-ups, and imaging for a maximum of 4 years or until diagnosis of lung cancer. The endobronchial brushes in DECAMP-1 will enable validation in the indeterminate nodule setting of a previously developed gene-expression classifier that has been shown to improve the diagnostic performance of bronchoscopy among intermediate risk patients [31]. Using methods outlined by Jung and colleagues we determined that at least 50 subjects in DECAMP-2 would need to develop lung cancer to provide 85% power at a false discovery rate less than 5% [46, 47]

Discussion

Background

Findings