Lung CancerMechLungCaNCT01710319
Mechanisms of Immunosurveillance for Lung Cancer
An observational study of Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- blood draw
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 7 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be patients that visit the Thoracic Surgery clinic or healthy volunteers.
Who may be able to join
- Age equal or greater to 18 years
- Ability to read and write in English
- Able to participate in the informed consent process
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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
- Being tested
- blood draw
- Keywords
- Immunoregulation, Natural Killer Cells
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: blood draw | |
| nonsmoker with lung cancer | patients that have smoked less than 100 cigarettes in their lifetime and have lung cancer Receives: Other: blood draw | |
| nonsmoker without lung cancer | patients that have smoked less than 100 cigarettes in their lifetime and do not have lung cancer Receives: Other: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of NK cells
The first outcome measure is the determination of the number of NK cells as a percentage of all CD45+cells.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startSep 2012
- Primary completion7 Jul 2016
- Study completion7 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Louis VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Alexander S Krupnick, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710319
- Sponsor's protocol ID
- 201110275
- Acronym
- MechLungCa
- Status last verified
- May 2018
- First submitted
- 11 Oct 2012
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12644540Bondy 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.
PubMed 19491091Murala 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Immunosurveillance for Lung Cancer
- ClinicalTrials.gov ID
- NCT01710319
- Acronym / sponsor ID
- MechLungCa / 201110275
- Conditions
- Lung Cancer
- Keywords
- Immunoregulation, Natural Killer Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Saint Louis VA Medical Center
- Study start
- Sep 2012
- Primary completion
- 7 Jul 2016 (actual)
- Study completion
- 7 Jul 2016 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| smoker with lung cancer | – | Other: blood drawpatients that smoke greater than 45 pack years or have end organ damage due to cigarette smoking and have lung cancer |
| smoker without lung cancer | – | Other: blood drawpatients that smoke greater than 45 pack years or have end organ damage due to cigarette smoking and do not have lung cancer |
| nonsmoker with lung cancer | – | Other: blood drawpatients that have smoked less than 100 cigarettes in their lifetime and have lung cancer |
| nonsmoker without lung cancer | – | Other: blood drawpatients that have smoked less than 100 cigarettes in their lifetime and do not have lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be patients that visit the Thoracic Surgery clinic or healthy volunteers.
Key inclusion criteria (3 listed)
- Age equal or greater to 18 years
- Ability to read and write in English
- Able to participate in the informed consent process
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawa 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. | Other | nonsmoker with lung cancer, nonsmoker without lung cancer, smoker with lung cancer, smoker without lung cancer |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 12644540Bach 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.
- Background: PubMed 19491091Bondy 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.
- BackgroundMurala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander S Krupnick, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01710319, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.