Detection of tumor DNA in plasma: definitive early diagnosis

Lung cancer is the leading cause of cancer death in the United States and will account for approximately 160,000 deaths in 2013. Although nearly always fatal when diagnosed in advanced stages, if it is caught at an early stage lung cancer can be cured in a significant number of patients. Recent work has shown that detecting lung cancer in early stages through screening is an effective way to reduce death from lung cancer. However, the best available method for lung cancer screening, a low dose computed tomography scan (LDCT), has been reported to have an extremely high false positive rate. This is a problem that prevents its use for lung cancer screening because these false positives lead to unnecessary invasive biopsy procedures, increased costs, and immeasurable anxiety for patients and their families. Thus, novel methods to augment or replace LDCT in the early detection of lung cancer are an important priority in lung cancer research.

We propose to develop a test for the early detection of lung cancer based on the ultrasensitive detection of material released from lung cancer cells into the bloodstream. Because early stage tumors are so small, the amount of material they release into the bloodstream is miniscule. However, we have developed a novel and extremely sensitive approach that can detect material released by tumor cells from a simple blood sample. Our test has shown the ability to detect the presence of cancer in patients with Stage I lung cancer, suggesting it has the potential to be used for early detection. We now propose to adapt our method specifically for the early detection of lung cancer by improving its sensitivity and accuracy to make it applicable for the early detection of lung cancer.