NK Cell Activity in Smokers Screened for Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Objectives: To examine whether NK cell activity associates with two confirmed risk factors:
      (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for
      potential confounders, including age, gender, body mass index (BMI), personal history of any
      cancer, and family history of cancer. This project is aimed at measuring NK cell activity,
      which may eventually help in reducing false positive rates of LDCT screening, improve early
      detection of lung cancer, and assist in risk assessment in patients with lung cancer. The
      investigators hypothesize that measurement of NK cell activity may be a useful tool for
      assessing changes in immunosurveillance in patients with conditions or diseases where NK cell
      activity has been shown to be reduced, such as lung cancer
    

Detailed description: 
      Lung cancer is the leading cause of cancer mortality in the United States. Despite
      considerable clinical research in multi-modality cancer treatment, there has been no
      significant decrease in lung cancer-specific mortality over the past three decades. The
      recent results of the National Lung Screening Trial (NLST) established that screening
      high-risk individuals using low-dose CT (LDCT) significantly reduces lung cancer-related
      mortality. One caveat is that approximately 96% of the "positive" results in the NLST were
      found not to be related to lung cancer. The difficulty in determining which subjects with
      suspicious lesions should be biopsied or operated on could be alleviated by the development
      of highly specific lung cancer biomarkers that could complement LDCT. Thus, novel,
      complementary, non-invasive diagnostic tools with high sensitivity and specificity would
      clearly be of enormous benefit to patients with a "positive" screening exam. This study will
      look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic
      device NK Vue™ in a cohort of current and former smokers (n=100) who meet the criteria for
      LDCT screening established by the National Comprehensive Cancer Network (NCCN) as a result of
      the positive findings from the NLST. This project is aimed at measuring the NK cell activity,
      which may eventually help in reducing false positive rates of LDCT screening, improve early
      detection of lung cancer, and assist in risk assessment in patients with lung cancer. The
      Investigators hypothesize that measurement of NK cell activity may be a useful tool for
      assessing changes in immunosurveillance in patients with conditions or diseases where NK cell
      activity has been shown to be reduced, such as lung cancer.

      Objectives Specific Aim 1: To examine whether NK cell activity associates with two confirmed
      risk factors: (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after
      controlling for potential confounders, including age, gender, body mass index (BMI), personal
      history of any cancer, and family history of cancer.

      Specific Aim 2 (Exploratory): In the study cohort, investigators expect approximately 45% of
      patients having at least one indeterminate lung nodule. Among those with lung nodule(s),
      investigators will examine whether NK cell activity associates with size of the largest lung
      nodule after controlling for potential confounders, including smoking exposure, age, gender,
      BMI, personal history of any cancer, and family history of cancer
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects must be ages 50 to 80 years and 364 days, and are males or females not of
        childbearing potential.
      
Biospecimen description: 
      Blood sample (1 ml) will be collected following a set of established Standard Operating
      Procedures (SOPs). Blood samples will be incubated for 20 hours after initial draw then
      centrifuged. Serum will then be frozen and stored at USC until they are sent to Cynvenio's
      CLIA and CAP certified laboratory in Thousand Oaks, CA for ELISA processing. All serum
      samples will be picked up by a Cynvenio representative who will personally deliver the
      specimens to the Cynvenio Labs.