Mechanisms of Immunosurveillance for Lung Cancer

NCT01710319 | Completed

• 1 other identifier: 201110275
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Immunoregulation; Natural Killer Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (4)

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

Other: blood draw

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

Other: blood draw

nonsmoker with lung cancer

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

Other: blood draw

nonsmoker without lung cancer

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

Other: blood draw

Interventions

blood draw 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; nonsmoker without lung cancer; smoker with lung cancer; smoker without lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients that visit the Thoracic Surgery clinic or healthy volunteers.

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Saint Louis VA Medical Center: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related 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. doi: 10.1093/jnci/95.6.470.

  PMID: 12644540 BACKGROUND

• 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.

  PMID: 19491091 BACKGROUND

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood draw will be obtained from patients in order to complete flow cytometry to analyze NK-specific markers to determine NK cell abundance and phenotypic expression. Obtain an optional blood draw on pts at least 30 days from the initial draw if transient confounders (viral infections or leukemoid reactions-a benign transient post-viral increase in WBCs) noted that could affect the NK Cell's behavior and interfere with the results.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexander S Krupnick, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 19, 2012
• Study Start: September 1, 2012
• Primary Completion: July 7, 2016
• Study Completion: July 7, 2016
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)