We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 87 for:    lung cancer AND risk factors

NK Cell Activity in Smokers Screened for Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02840578
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease
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


Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Lung Cancer
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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
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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • At the time of registration, subjects must have a current or previous cumulative cigarette smoking history of ≥ 20 pack years (packs per day multiplied by the number of years smoked). If smoking history is between 20 and 29 pack years, subjects must have an additional risk factor (i.e. radon exposure, occupational exposure, personal history of smoking-associated cancer, family history of lung cancer in first-degree relatives, COPD or pulmonary fibrosis).
  • At the time of registration former smokers without additional risk factor(s) must have quit smoking within the preceding 15 years.
  • Subjects must be willing to provide blood samples as biospecimens for the study.
  • At the time of registration, subjects must have recovered from the toxic effects of prior therapy: ≥6 months (182 days) from the last dose of prior cytotoxic therapy.
  • At the time of registration, subjects must have recovered from the effects of prior pneumonia or acute respiratory infection treated by antibiotics by a physician: ≥12 weeks (84 days) from the first dose of antibiotics.

Exclusion Criteria:

  • Medical or psychiatric condition precluding informed medical consent.
  • Prior history of lung cancer.
  • Treatment for or advisement by a physician of evidence of any cancer within the past five years, with the exceptions of non-melanoma skin cancer and most in-situ carcinomas. (Treatment for, or evidence of, melanoma or in-situ bladder/transition cell carcinomas within the preceding five years renders the potential participant ineligible.)
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Beringia Liu 213-304-3044 Beringia.Liu@med.usc.edu
Contact: Letty Vasquez-Caldera 213-304-3886 Leticia.Vasquez-Caldera@med.usc.edu

Locations
United States, California
USC Department of Radiology Recruiting
Los Angeles, California, United States, 90033
Contact: Beringia Liu    213-304-3044    Beringia.Liu@med.usc.edu   
Contact: Letty Vasquez-Caldera    213-304-3886    Leticia.Vasquez-Caldera@med.usc.edu   
Principal Investigator: Christopher Lee, MD         
Sponsors and Collaborators
University of Southern California
ATGen Global
Investigators
Principal Investigator: Christopher Lee, MD University of Southern California
More Information