| Popis: |
The purpose of this work is to develop and validate molecular biomarkers found in blood, other bodily fluids, or tissues, which may be used for the early detection of lung cancer in Military Treatment Facilities and Veteran s Administration Hospitals. Over the course of the second year of this award, we have maintained and appropriately modified the administrative infrastructure needed for two distinct clinical trials. Prototol 1, the validation of non-invasive biomarkers to distinguish cancer from benign lesions among patients with pulmonary nodules, has received full approval to begin recruitment at all 14 clinical sites. We have thus far enrolled 30 subjects from ten of the clinical sites, and have transferred clinical data imaging and biospecimens from the clinical sites to the coordinating centers. We are currently evaluating the quality of RNA obtained from biospecimens from sites that have recruited at least 3 subjects. We have also modified the inclusion criteria for this protocol based on feedback from the clinical sites. Protocol 2 will recruit a cross-sectional cohort of smokers with early stage lung cancer (n=50) and matched controls (n=30) along with a longitudinal cohort of 800 high-risk smokers in order to develop molecular biomarkers for the preclinical detection of lung cancer. This protocol has obtained regulatory approval at four sites who are currently screening eligible candidates for recruitment purposes. We have appropriately modified our administrative infrastructure to maximize efficiency and clear communication between sites and Boston University. We have also modified biospecimen collection and shipping procedures accordingly, after collecting and reviewing feedback. Based on the above progress, we are strongly positioned to further recruitment into both protocols during the coming year, ultimately helping to develop non-invasive measures for the early detection of lung cancer. |
