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Small cell lung cancer (SCLC) is one of the few malignancies with such poor outcomes that it meets the definition
of a "recalcitrant" cancer, accounting for 30,000 American lives each year with five-year survival rates of just
~7%. Somewhat lost in these dismal statistics is the fact that patients diagnosed early (limited stage) display
vastly superior survival metrics when compared to those diagnosed late (extensive stage). Unfortunately, only a
minority of cases are identified at limited stage, and the CT screening approaches capable of early detection for
non-small cell lung cancer (NSCLC) have not proven effective for SCLC. We employ a novel hybrid plasma
marker panel capable of detecting proteomic and autoantibody markers for SCLC early detection. We have
accumulated very positive discovery and confirmatory data centered around paraneoplastic syndrome (PNS)
autoantibodies using the Cardiovascular Health Study (prediagnostic), Fred Hutch Lung Cancer Early Detection
and Prevention Clinic (LCEDPC), and Vanderbilt SCLC cohort samples. One of the major problems with SCLC
is that there are few studies and cohorts of any size available with plasma as there currently is little ongoing
research due to its intractability. The WHI helpdesk estimates there are 71 SCLC cases diagnosed within 3
years of a blood draw in the observational study (OS) and clinical trial (CT). Thus, we request 250 μl of all of
these samples (baseline and year 3, justified below) plus 2 matched controls to attempt to validate our biomarker
candidates using a nested case-control design.
Specific Aims:
Specific Aim #1: Validation of autoantibody and proteomic, plasma markers for the early detection of SCLC
Specific Aim #2: Establish the maximal time interval prior to diagnosis that hybrid plasma markers are
capable of identifying SCLC