NK Cell Activity in Smokers Screened for Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02840578|
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : May 11, 2018
|Condition or disease|
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
|Study Type :||Observational|
|Actual Enrollment :||242 participants|
|Official Title:||Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Lung Cancer|
|Actual Study Start Date :||December 16, 2016|
|Actual Primary Completion Date :||March 5, 2018|
|Actual Study Completion Date :||March 5, 2018|
- The association between NK cell activity and presence of lung nodule and smoking exposure (pack-years), [ Time Frame: 1 year ]Multivariate generalized linear model will be used to examine the association controlling for potential confounders including age, gender, BMI, personal history of any cancer, and family history of cancer.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840578
|United States, California|
|USC Department of Radiology|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Christopher Lee, MD||University of Southern California|