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OpenTrials
Completed

NCT Number: NCT01710319

Mechanisms of Immunosurveillance for Lung Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of NK cells

    Time frame: 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 outcomes

  1. Expression of CD11b

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Saint Louis VA Medical Center

Registry information

Acronym: MechLungCa

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2012
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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