Lung CancerNCT02840578
NK Cell Activity in Smokers Screened for Lung Cancer
An observational study of Lung Cancer, run by University of Southern California at 1 site in United States.
Trial summary
Objectives: To examine whether NK cell activity associates with two confirmed risk factors: (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for potential confounders, including age, gender, body mass index (BMI), personal history of any cancer, and family history of cancer. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2016to 5 Mar 2018
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects must be ages 50 to 80 years and 364 days, and are males or females not of childbearing potential.
Who may be able to join
- At the time of registration, subjects must have a current or previous cumulative cigarette smoking history of ≥ 20 pack years (packs per day multiplied by the number of years smoked). If smoking history is between 20 and 29 pack years, subjects must have an additional risk factor (i.e. radon exposure, occupational exposure, personal history of smoking-associated cancer, family history of lung cancer in first-degree relatives, COPD or pulmonary fibrosis).
- At the time of registration former smokers without additional risk factor(s) must have quit smoking within the preceding 15 years.
- Subjects must be willing to provide blood samples as biospecimens for the study.
- At the time of registration, subjects must have recovered from the toxic effects of prior therapy: ≥6 months (182 days) from the last dose of prior cytotoxic therapy.
- At the time of registration, subjects must have recovered from the effects of prior pneumonia or acute respiratory infection treated by antibiotics by a physician: ≥12 weeks (84 days) from the first dose of antibiotics.
Who cannot join
- Medical or psychiatric condition precluding informed medical consent.
- Prior history of lung cancer.
- Treatment for or advisement by a physician of evidence of any cancer within the past five years, with the exceptions of non-melanoma skin cancer and most in-situ carcinomas. (Treatment for, or evidence of, melanoma or in-situ bladder/transition cell carcinomas within the preceding five years renders the potential participant ineligible.)
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Department of Radiology
Los Angeles, California, 90033
About this study
Official title: Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Lung Cancer
Objectives: To examine whether NK cell activity associates with two confirmed risk factors: (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for potential confounders, including age, gender, body mass index (BMI), personal history of any cancer, and family history of cancer. This project is aimed at measuring NK cell activity, which may eventually help in reducing false positive rates of LDCT screening, improve early detection of lung cancer, and assist in risk assessment in patients with lung cancer. The investigators hypothesize that measurement of NK cell activity may be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be reduced, such as lung cancer
Read the detailed description
Lung cancer is the leading cause of cancer mortality in the United States. Despite considerable clinical research in multi-modality cancer treatment, there has been no significant decrease in lung cancer-specific mortality over the past three decades. The recent results of the National Lung Screening Trial (NLST) established that screening high-risk individuals using low-dose CT (LDCT) significantly reduces lung cancer-related mortality. One caveat is that approximately 96% of the "positive" results in the NLST were found not to be related to lung cancer. The difficulty in determining which subjects with suspicious lesions should be biopsied or operated on could be alleviated by the development of highly specific lung cancer biomarkers that could complement LDCT. Thus, novel, complementary, non-invasive diagnostic tools with high sensitivity and specificity would clearly be of enormous benefit to patients with a "positive" screening exam. This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue™ in a cohort of current and former smokers (n=100) who meet the criteria for LDCT screening established by the National Comprehensive Cancer Network (NCCN) as a result of the positive findings from the NLST. This project is aimed at measuring the NK cell activity, which may eventually help in reducing false positive rates of LDCT screening, improve early detection of lung cancer, and assist in risk assessment in patients with lung cancer. The Investigators hypothesize that measurement of NK cell activity may be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be reduced, such as lung cancer.
Objectives Specific Aim 1: To examine whether NK cell activity associates with two confirmed risk factors: (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for potential confounders, including age, gender, body mass index (BMI), personal history of any cancer, and family history of cancer.
Specific Aim 2 (Exploratory): In the study cohort, investigators expect approximately 45% of patients having at least one indeterminate lung nodule. Among those with lung nodule(s), investigators will examine whether NK cell activity associates with size of the largest lung nodule after controlling for potential confounders, including smoking exposure, age, gender, BMI, personal history of any cancer, and family history of cancer
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between NK cell activity and presence of lung nodule and smoking exposure (pack-years),
Multivariate generalized linear model will be used to examine the association controlling for potential confounders including age, gender, BMI, personal history of any cancer, and family history of cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start16 Dec 2016
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
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 University of Southern CaliforniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- ATGen Global
- Responsible party
- Principal investigator, Christopher Lee, University of Southern California
- Investigators
- Christopher Lee, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840578
- Sponsor's protocol ID
- NK Cell Activity
- Status last verified
- May 2018
- First submitted
- 14 Jul 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18.
PubMed 24561245Koo KC, Shim DH, Yang CM, Lee SB, Kim SM, Shin TY, Kim KH, Yoon HG, Rha KH, Lee JM, Hong SJ. Reduction of the CD16(-)CD56bright NK cell subset precedes NK cell dysfunction in prostate cancer. PLoS One. 2013 Nov 4;8(11):e78049. doi: 10.1371/journal.pone.0078049. eCollection 2013.
PubMed 24223759
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of NK Cell Activity in Whole Blood in Subjects Being Screened for Lung Cancer
- ClinicalTrials.gov ID
- NCT02840578
- Acronym / sponsor ID
- NK Cell Activity
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- ATGen Global
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 21 Jul 2016 (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.
Objectives: To examine whether NK cell activity associates with two confirmed risk factors: (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for potential confounders, including age, gender, body mass index (BMI), personal history of any cancer, and family history of cancer. This project is aimed at measuring NK cell activity, which may eventually help in reducing false positive rates of LDCT screening, improve early detection of lung cancer, and assist in risk assessment in patients with lung cancer. The investigators hypothesize that measurement of NK cell activity may be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be reduced, such as lung cancer
Detailed description
Lung cancer is the leading cause of cancer mortality in the United States. Despite considerable clinical research in multi-modality cancer treatment, there has been no significant decrease in lung cancer-specific mortality over the past three decades. The recent results of the National Lung Screening Trial (NLST) established that screening high-risk individuals using low-dose CT (LDCT) significantly reduces lung cancer-related mortality. One caveat is that approximately 96% of the "positive" results in the NLST were found not to be related to lung cancer. The difficulty in determining which subjects with suspicious lesions should be biopsied or operated on could be alleviated by the development of highly specific lung cancer biomarkers that could complement LDCT. Thus, novel, complementary, non-invasive diagnostic tools with high sensitivity and specificity would clearly be of enormous benefit to patients with a "positive" screening exam. This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue™ in a cohort of current and former smokers (n=100) who meet the criteria for LDCT screening established by the National Comprehensive Cancer Network (NCCN) as a result of the positive findings from the NLST. This project is aimed at measuring the NK cell activity, which may eventually help in reducing false positive rates of LDCT screening, improve early detection of lung cancer, and assist in risk assessment in patients with lung cancer. The Investigators hypothesize that measurement of NK cell activity may be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be reduced, such as lung cancer.
Objectives Specific Aim 1: To examine whether NK cell activity associates with two confirmed risk factors: (1) presence of indeterminate lung nodule(s) and (2) smoking exposure after controlling for potential confounders, including age, gender, body mass index (BMI), personal history of any cancer, and family history of cancer.
Specific Aim 2 (Exploratory): In the study cohort, investigators expect approximately 45% of patients having at least one indeterminate lung nodule. Among those with lung nodule(s), investigators will examine whether NK cell activity associates with size of the largest lung nodule after controlling for potential confounders, including smoking exposure, age, gender, BMI, personal history of any cancer, and family history of cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must be ages 50 to 80 years and 364 days, and are males or females not of childbearing potential.
Key inclusion criteria (5 listed)
- At the time of registration, subjects must have a current or previous cumulative cigarette smoking history of ≥ 20 pack years (packs per day multiplied by the number of years smoked). If smoking history is between 20 and 29 pack years, subjects must have an additional risk factor (i.e. radon exposure, occupational exposure, personal history of smoking-associated cancer, family history of lung cancer in first-degree relatives, COPD or pulmonary fibrosis).
- At the time of registration former smokers without additional risk factor(s) must have quit smoking within the preceding 15 years.
- Subjects must be willing to provide blood samples as biospecimens for the study.
- At the time of registration, subjects must have recovered from the toxic effects of prior therapy: ≥6 months (182 days) from the last dose of prior cytotoxic therapy.
- At the time of registration, subjects must have recovered from the effects of prior pneumonia or acute respiratory infection treated by antibiotics by a physician: ≥12 weeks (84 days) from the first dose of antibiotics.
Key exclusion criteria (3 listed)
- Medical or psychiatric condition precluding informed medical consent.
- Prior history of lung cancer.
- Treatment for or advisement by a physician of evidence of any cancer within the past five years, with the exceptions of non-melanoma skin cancer and most in-situ carcinomas. (Treatment for, or evidence of, melanoma or in-situ bladder/transition cell carcinomas within the preceding five years renders the potential participant ineligible.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The association between NK cell activity and presence of lung nodule and smoking exposure (pack-years),
Time frame: 1 year
Multivariate generalized linear model will be used to examine the association controlling for potential confounders including age, gender, BMI, personal history of any cancer, and family history of cancer.
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 11 May 2018.
- Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Background: PubMed 24561245Lee SB, Cha J, Kim IK, Yoon JC, Lee HJ, Park SW, Cho S, Youn DY, Lee H, Lee CH, Lee JM, Lee KY, Kim J. A high-throughput assay of NK cell activity in whole blood and its clinical application. Biochem Biophys Res Commun. 2014 Mar 14;445(3):584-90. doi: 10.1016/j.bbrc.2014.02.040. Epub 2014 Feb 18.
- Background: PubMed 24223759Koo KC, Shim DH, Yang CM, Lee SB, Kim SM, Shin TY, Kim KH, Yoon HG, Rha KH, Lee JM, Hong SJ. Reduction of the CD16(-)CD56bright NK cell subset precedes NK cell dysfunction in prostate cancer. PLoS One. 2013 Nov 4;8(11):e78049. doi: 10.1371/journal.pone.0078049. eCollection 2013.
- Individual participant dataSharing planned: Undecided
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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.
Christopher Lee, MD principal investigator
University of Southern California
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 University of Southern California 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 5 inclusion and 3 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 11 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?
The association between NK cell activity and presence of lung nodule and smoking exposure (pack-years), (time frame: 1 year). 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 NCT02840578, 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 11 May 2018.