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Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules


N/A
50 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Detection of Early Lung Cancer Among Military Personnel Study 1 (DECAMP-1): Diagnosis and Surveillance of Indeterminate Pulmonary Nodules


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 one academic
hospital 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-2cm) 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.


Inclusion Criteria:



- 50 years of age or older;

- Initial diagnosis of indeterminate pulmonary nodule (0.7-2.0 cm);

- Smoking status: Current or former smoker with ≥ 30 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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Lung Cancer

Outcome Description:

Subjects will be identified as Lung Cancer or no Lung Cancer (through diagnosis) within the 2 year followup period.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Avrum Spira, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston University

Authority:

United States: Department of Defense: HRPO: Dr. Julie Wilberding

Study ID:

DECAMP-1

NCT ID:

NCT01785342

Start Date:

January 2013

Completion Date:

September 2016

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

Name

Location

Walter Reed National Military Medical CenterBethesda, Maryland  20889
Naval Medical Center San DiegoSan Diego, California  92134
Naval Medical Center PortsmouthPortsmouth, Virginia  23708
Veterans Research Foundation of PittsburghPittsburgh, Pennsylvania  15240
San Antonio Military Medical CenterFort Sam Houston, Texas  78234
Regents of the University of California LA (Los Angeles VA Healthcare System)Los Angeles, California  
Denver Research InstituteDenver, Colorado  
Boston VA Research Institute, IncBoston, Massachusetts  
Health Research Inc. Roswell Park DivisionBuffalo, New York  
Trustees of University of Pennsylvania (Philadelphia VA Medical Center)Philadelphi, Pennsylvania  
Middle Tennessee Research Institute (Vanderbilt University)Nashville, Tennessee  
Dallas VA Research CorporationDallas, Texas