(Boston) - Boston University School of Medicine (BUSM) is the lead institution on a $13.6 million study aimed at developing novel technologies for the early detection of lung cancer. The five-year multi-site, multi-phase study that will focus on active military personnel and veterans is funded by the United States Department of Defense (DOD) Lung Cancer Research Program and will be conducted under the direction of principal investigator Avrum Spira, MD, MSc, associate professor of medicine, pathology and bioinformatics at BUSM and a pulmonologist at Boston Medical Center (BMC).
BUSM will collaborate with military hospitals and Veteran's Affairs medical centers across the country that collectively have the ability to investigate a large number of patients and gain access to a diverse variety of researchers and tools. The Detecting Early Lung Cancer Among Military Personnel (DECAMP) Consortium represents the largest consortium of researchers dedicated to identifying non-invasive ways to detect lung cancer early. Mitchell D. Schnall, MD, PhD, the Matthew J. Wilson professor of radiology at the University of Pennsylvania and chair of the American College of Radiology Imaging Network (ACRIN), will serve as co-principal investigator.
In the military population, smoking rates are about 50 percent higher than the civilian population, and veterans in particular are 25-75 percent more likely to develop lung cancer than non-veterans. There has been an increase in smoking among members of the armed forces stationed in Afghanistan and Iraq, and the rate is 50 percent higher in deployed vs. non-deployed personnel. Additionally, the exposure of other substances in the air when in combat, including radon, asbestos and fuel exhaust, is elevated among military personnel.
"Current lung cancer detection methods involve invasive procedures that are often done only after symptoms occur, and by that time, the cancer has spread outside of the lungs and can be difficult to treat," said Spira. "Using advanced imaging techniques and testing molecular biomarkers that indicate risk of a future lung cancer diagnosis will help in the development of non-invasive, accurate methods to detect lung cancer before it becomes untreatable."
The DECAMP consortium will address two critical clinical questions that are the direct consequence of the recently completed National Lung Screening Trial (NLST). Results from that study indicate that lung cancer screening with low-dose computed tomography (CT) scans of the chest can reduce lung cancer mortality among individuals at a high risk of developing the disease. One of the limitations of the CT scans in that study was the high false positive rate; nearly 24% of smokers in the NLST trial had an abnormality on the CT scans that was considered positive for lung cancer. However, only 4% of these turned out to be lung cancer while 96% were false-positive results.
Through the DECAMP consortium, Spira and his colleagues will use molecular biomarkers to more accurately distinguish between benign and cancerous lung nodules observed on CT scans. This first phase of the study will look at a group of 500 current and former smokers whose CT scans showed small pulmonary nodules that represent a diagnostic dilemma in terms of which patients will need an invasive work up via lung biopsy versus those patients that can be managed conservatively with follow up imaging studies.
The goal of the second phase of the study is to identify biomarkers that can predict which smokers are at risk for future development of lung cancer among those without any symptoms or abnormalities on CT scans of the chest. There will be approximately 1,000 high-risk subjects recruited for this phase. They will be followed for 4-5 years with the objective of discovering the biomarkers that can identify those at risk for developing lung cancer who would most benefit from both more intense screening efforts via annual CT scans, as well as treatment as part of ongoing clinical trials with new agents that may prevent lung cancer.
"The non-invasive methods to be developed will have the capability to distinguish between patients with or without lung cancer, as well as identify patients who show early signs of a higher risk for the disease," said Spira, who is also the chief of the division of Computational Biomedicine within the department of medicine at BUSM. "Lung cancer is the most lethal of all cancers, and this research could potentially lead to less people dying from the disease."
Marc Lenburg, PhD, associate professor of medicine and pathology and laboratory medicine at BUSM, will lead the Genomics Core. Under Schnall's direction, ACRIN--one of the two organizations that carried out the NLST--will manage development of the research protocols, regulatory oversight and all research image and clinical data collection. The research institutions collaborating in this study include the following: The University of Texas MD Anderson Cancer Center; Brown University and the University of California, Los Angeles. The clinical collaborators are: VA Boston Healthcare System; Dallas VA Medical Center; Denver VA Medical Center; Greater Los Angeles VA Healthcare System; VA Tennessee Valley Healthcare System; Philadelphia VA Medical Center; VA Pittsburgh Medical Center; and Roswell Park Cancer Institute. The military training centers involved include: National Naval Medical Center; Naval Medical Center Portsmouth; San Antonio Military Medical Center; and Naval Medical Center San Diego.
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