Mechanisms of Immunosurveillance for Lung Cancer

Completed

• Conditions: Lung Cancer
• Interventions: Other: blood draw

• Registration Number: NCT01710319
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this research study is to investigate the differences in "natural killer (NK) blood cells, a type of white blood cell that fights infection in the body, among different types of patients that have lung surgery. The four different groups of patients are:

* smokers with lung cancer

* smokers without lung cancer

* non-smokers with lung cancer

* non-smokers without lung cancer.

Detailed Description

Research has shown that different strains of mice possess varying susceptibility to lung cancer. C3H and C57BL6 mice are highly resistant to lung cancer, whereas A/J and 129 mice are very susceptible to lung cancer. Data from our lab shows that the mice have different numbers of natural killer (NK) cells as well as different characteristics of those cells. C3H and C57BL6 mice have higher numbers of NK cells as well as higher expression of CD11b, whereas A/J and 129 mice have lower numbers and lower expression.

These findings justify parallel investigation of NK cells in human populations resistant and susceptible to lung cancer. Through blood samples, circulating NK cells can be counted and phenotypically analyzed. Smoking can be used as a factor to establish lung cancer risk. Additionally, non-smokers suffering from lung cancer provide an opportunity to investigate whether lung cancer patients have lower abundance of NK cells and lesser expression of CD11b, independent of the effects of smoking.

Objective:

The main goal of this study is to investigate the quantitative and phenotypic differences in circulating NK cells among human populations. Participants will be classified as heavy smokers (HS), non-smokers (NS), those suffering from lung cancer (LC), and those free from lung cancer (NC).

Hypothesis #1: NS/LC participants will have fewer NK cells and lower expression of CD11b compared to HS/NC and NS/NC participants.

Hypothesis #2: NS/LC participants will have more numerous NK cells and higher expression of CD11b compared to HS/LC participants.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-19
• Primary Completion: 2016-07-07
• Study Completion: 2016-07-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Age equal or greater to 18 years
• Ability to read and write in English
• Able to participate in the informed consent process

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Exclusion Criteria

• Known active hepatitis B, hepatitis C, or HIV/AIDs (found in medical record)
• Chemotherapy or radiation therapy within 3 months of enrollment
• Type 1 Diabetes Mellitus
• Rheumatoid arthritis, Lupus, Multiple Sclerosis, or any other autoimmune disease as deemed necessary for exclusion by the Principal Investigator
• Previous organ transplant
• Blood transfusion within 3 months prior to enrollment
• Any previous cancer, excluding a previous lung cancer
• Steroid use within 4 weeks of enrollment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nonsmoker without lung cancer	blood draw	patients that have smoked less than 100 cigarettes in their lifetime and do not have lung cancer
smoker with lung cancer	blood draw	patients that smoke greater than 45 pack years or have end organ damage due to cigarette smoking and have lung cancer
nonsmoker with lung cancer	blood draw	patients that have smoked less than 100 cigarettes in their lifetime and have lung cancer
smoker without lung cancer	blood draw	patients that smoke greater than 45 pack years or have end organ damage due to cigarette smoking and do not have lung cancer

Primary Outcome Measures

Name	Time	Method
Number of NK cells	Within 5 minutes of blood arrival to lab, processing begins and blood is frozen. Flow cytometry will be completed 1 to 3 months after blood is frozen. Data presentation in 1 to 2 years.	The first outcome measure is the determination of the number of NK cells as a percentage of all CD45+cells.

Secondary Outcome Measures

Name	Time	Method
Expression of CD11b	Within 5 minutes of blood arrival to the lab, processing begins and blood is frozen. Flow cytometry will be completed 1 to 3 months after blood is frozen. Data presentation in 1 to 2 years.	Expression of CD11b determined by flow cytometry as compared to control (nonsmoker/no cancer cohort. Flow cytometry will be used to analyze NK-specific markers in the blood samples to determine NK cell abundance and phenotypic expression. The NS/NC cohort will serve as the control for measuring CD11b expression.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States