NK Cell Activity in Smokers Screened for Lung Cancer

NCT02840578 | Completed

• 1 other identifier: NK Cell Activity
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The association between NK cell activity and presence of lung nodule and smoking exposure (pack-years),

  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.

  1 year

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Southern California: lead
• ATGen Global: collaborator

Study Sites (1)

USC Department of Radiology

Los Angeles, California, 90033, United States

Location

Related Publications (3)

• National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

  PMID: 21714641 BACKGROUND

• Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18.

  PMID: 24561245 BACKGROUND

• Koo KC, Shim DH, Yang CM, Lee SB, Kim SM, Shin TY, Kim KH, Yoon HG, Rha KH, Lee JM, Hong SJ. Reduction of the CD16(-)CD56bright NK cell subset precedes NK cell dysfunction in prostate cancer. PLoS One. 2013 Nov 4;8(11):e78049. doi: 10.1371/journal.pone.0078049. eCollection 2013.

  PMID: 24223759 BACKGROUND

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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Christopher Lee, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 21, 2016
• Study Start: December 16, 2016
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)