Clinical trial NCT01710319: Mechanisms of Immunosurveillance for Lung Cancer
Official title: Mechanisms of Immunosurveillance for Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Immunoregulation
Natural Killer Cells
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Saint Louis VA Medical Center
First posted: 2012-10-19
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients that visit the Thoracic Surgery clinic or healthy volunteers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of NK cells
timeFrame: 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 outcomes:
measure: Expression of CD11b
timeFrame: 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.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alexander S Krupnick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/jnci/95.6.470.
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.
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.