Mechanisms of Immunosurveillance for Lung Cancer

Lung Cancer Clinical Trial

— MechLungCa  

Official title:

Mechanisms of Immunosurveillance for Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710319
• Other study ID #: 201110275
• Status: Completed
• Start date: September 2012
• Est. completion date: July 7, 2016

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 7, 2016
• Est. primary completion date: July 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age equal or greater to 18 years

• Ability to read and write in English

• Able to participate in the informed consent process

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• blood draw
a blood specimen will be obtained from each patient in the four groups. An optional blood draw after 30 days of initial blood specimen if indicated.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Saint Louis VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bach PB, Kattan MW, Thornquist MD, Kris MG, Tate RC, Barnett MJ, Hsieh LJ, Begg CB. Variations in lung cancer risk among smokers. J Natl Cancer Inst. 2003 Mar 19;95(6):470-8. — View Citation

Bondy SJ, Victor JC, Diemert LM. Origin and use of the 100 cigarette criterion in tobacco surveys. Tob Control. 2009 Aug;18(4):317-23. doi: 10.1136/tc.2008.027276. Epub 2009 Jun 1. — View Citation

Murala SS, Gelman AE, Kreisel D, Krupnick AS. Natural killer cells play a critical role in immunosurveillance for murine lung cancer. American Surgical Congress, Proceedings in The Journal of Surgical Research 2011; 165: 292-293.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of NK cells	The first outcome measure is the determination of the number of NK cells as a percentage of all CD45+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.
Secondary	Expression of CD11b	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.	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.