Mechanisms of Immunosurveillance for Lung Cancer

NCT ID: NCT01710319

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-07-07

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

smoker with lung cancer

patients that smoke greater than 45 pack years or have end organ damage due to cigarette smoking and have lung cancer

blood draw

Intervention Type: OTHER

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.

smoker without lung cancer

patients that smoke greater than 45 pack years or have end organ damage due to cigarette smoking and do not have lung cancer

blood draw

Intervention Type: OTHER

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.

nonsmoker with lung cancer

patients that have smoked less than 100 cigarettes in their lifetime and have lung cancer

blood draw

Intervention Type: OTHER

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.

nonsmoker without lung cancer

patients that have smoked less than 100 cigarettes in their lifetime and do not have lung cancer

blood draw

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saint Louis VA Medical Center

FED

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander S Krupnick, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12644540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19491091 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

201110275

Identifier Type: -

Identifier Source: org_study_id