DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
- Conditions
- Pulmonary Disease
- Interventions
- Other: Biosamples from airway and blood
- Registration Number
- NCT02504697
- Lead Sponsor
- Boston University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 665
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Longitudinal Cohort Biosamples from airway and blood 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.
- Primary Outcome Measures
Name Time Method Lung Cancer Four years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Trustees of University of Pennsylvania (Philadelphia VA Medical Center)
🇺🇸Philadelphia, Pennsylvania, United States
Dallas VA Research Corporation
🇺🇸Dallas, Texas, United States
Naval Medical Center Portsmouth
🇺🇸Portsmouth, Virginia, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Boston VA Research Institute, Inc
🇺🇸Boston, Massachusetts, United States
Veterans Research Foundation of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Naval Medical Center San Diego
🇺🇸San Diego, California, United States
San Antonio Military Medical Center
🇺🇸San Antonio, Texas, United States
Middle Tennessee Research Institute (Vanderbilt University)
🇺🇸Nashville, Tennessee, United States
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
Denver Research Institute
🇺🇸Denver, Colorado, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Health Research Inc. Roswell Park Division
🇺🇸Buffalo, New York, United States