Tobacco Use DisorderNCT00218179
Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1
An observational study of Tobacco Use Disorder and Lung Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Lung Cancer
- What is being tested?
- Non-intervention
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2007
- 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 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Case-control study nested within the Prostate Lung Colorectal and Ovarian Cancer Screening Trial. Subjects consisted of screening arm subjects who were smokers at baseline and who contributed biorepository samples at the first screening visit.
Who may be able to join
- Screening arm participants in the Prostate, Lung, Colon, and Ovarian Screen Trial (PLCO)
- Reported smoking on baseline questionnaire of PLCO
- Contributed biorepository samples
Who cannot join
- Unstable physical or mental health
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial
Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.
Read the detailed description
Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer.
Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.
This observational case-control study will involve a random selection from a group of smokers who are participating in the Prostrate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial. The chosen cases will include 300 incident lung cancer cases and 300 controls (participants who have had no diagnosis of lung cancer). Demographic and baseline data from the PLCO database will be obtained. Prior baseline blood samples from the PLCO trial will be obtained as well. Based on age, sex, and smoking history, participants will be grouped into triplets in order to pool their blood samples. These samples will then be analyzed to determine whether distributions of biomarker levels in lung cancer participants differ from those in non-lung cancer participants. This study will not involve recruitment of any participants, as data and samples from the PLCO trial will be used and no new blood samples will be obtained.
- Conditions
- Tobacco Use Disorder, Lung Cancer
- Being tested
- Non-intervention
- Keywords
- Lung Cancer, Cotinine, NNAL, Carcinogens, Case-control, SNPs
- Medical subject headings
- Tobacco Use Disorder, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionOther
Also called NNAL-glucuronide, phenanthrene tetraol
Measured total NNAL and PheT as biomarkers of exposure
| Study group | Role | What they receive |
|---|---|---|
| Cases | Lung cancer cases diagnosed prior to 2007 among baseline smokers in the PLCO Receives: Other: Non-intervention | |
| Controls | Subjects without lung cancer among smokers at baseline in the PLCO study Receives: Other: Non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer
Measured: Cumulative incidence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2007
- Study completionDec 2007
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 Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Timothy Church, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218179
- Sponsor's protocol ID
- NIDA-13333-1
- Other IDs
- P50DA013333
- Status last verified
- Jan 2017
- First submitted
- 16 Sep 2005
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Church TR, Haznadar M, Geisser MS, Anderson KE, Caporaso NE, Le C, Abdullah SB, Hecht SS, Oken MM, Van Ness B. Interaction of CYP1B1, cigarette-smoke carcinogen metabolism, and lung cancer risk. Int J Mol Epidemiol Genet. 2010 Aug 5;1(4):295-309.
PubMed 21532841Church TR, Anderson KE, Caporaso NE, Geisser MS, Le CT, Zhang Y, Benoit AR, Carmella SG, Hecht SS. A prospectively measured serum biomarker for a tobacco-specific carcinogen and lung cancer in smokers. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):260-6. doi: 10.1158/1055-9965.EPI-08-0718.
PubMed 19124507Fang G, Haznadar M, Wang W, Yu H, Steinbach M, Church TR, Oetting WS, Van Ness B, Kumar V. High-order SNP combinations associated with complex diseases: efficient discovery, statistical power and functional interactions. PLoS One. 2012;7(4):e33531. doi: 10.1371/journal.pone.0033531. Epub 2012 Apr 19.
PubMed 22536319
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial
- ClinicalTrials.gov ID
- NCT00218179
- Acronym / sponsor ID
- NIDA-13333-1
- Conditions
- Tobacco Use Disorder, Lung Cancer
- Keywords
- Lung Cancer, Cotinine, NNAL, Carcinogens, Case-control, SNPs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Sep 2005 (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.
Lung cancer is the leading cause of cancer death in the United States. Currently it remains impossible to predict which smokers will get cancer. Each puff of a cigarette delivers a mixture of over 60 known carcinogens. Biomarkers that quantify carcinogen levels and metabolism are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.
Detailed description
Lung cancer is the leading cause of cancer death in the United States. Approximately 90% of lung cancer is caused by cigarette smoking. While most lung cancer cases occur in smokers or ex-smokers, only 15-25% of smokers will get lung cancer. Currently it remains impossible to predict which smokers will get cancer.
Each puff of a cigarette delivers, along with nicotine, a mixture of over 60 known carcinogens. Most of these carcinogens require metabolic activation before they can negatively affect cell DNA and cause cancer. Biomarkers that quantify carcinogen levels and metabolic activity of carcinogens are a useful tool and available to use. The purpose of this study is to assess the link between tobacco smoke carcinogen biomarkers and the risk of developing lung cancer.
This observational case-control study will involve a random selection from a group of smokers who are participating in the Prostrate, Lung, Colon, and Ovarian Cancer (PLCO) Screen Trial. The chosen cases will include 300 incident lung cancer cases and 300 controls (participants who have had no diagnosis of lung cancer). Demographic and baseline data from the PLCO database will be obtained. Prior baseline blood samples from the PLCO trial will be obtained as well. Based on age, sex, and smoking history, participants will be grouped into triplets in order to pool their blood samples. These samples will then be analyzed to determine whether distributions of biomarker levels in lung cancer participants differ from those in non-lung cancer participants. This study will not involve recruitment of any participants, as data and samples from the PLCO trial will be used and no new blood samples will be obtained.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Non-interventionLung cancer cases diagnosed prior to 2007 among baseline smokers in the PLCO |
| Controls | – | Other: Non-interventionSubjects without lung cancer among smokers at baseline in the PLCO study |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case-control study nested within the Prostate Lung Colorectal and Ovarian Cancer Screening Trial. Subjects consisted of screening arm subjects who were smokers at baseline and who contributed biorepository samples at the first screening visit.
Key inclusion criteria (3 listed)
- Screening arm participants in the Prostate, Lung, Colon, and Ovarian Screen Trial (PLCO)
- Reported smoking on baseline questionnaire of PLCO
- Contributed biorepository samples
Key exclusion criteria (1 listed)
- Unstable physical or mental health
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 |
|---|---|---|
| Non-interventionAlso: NNAL-glucuronide, phenanthrene tetraolMeasured total NNAL and PheT as biomarkers of exposure | Other | Cases, Controls |
Primary outcome
Lung cancer
Time frame: Cumulative incidence
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 23 Jan 2017.
- Results publication: PubMed 21532841Church TR, Haznadar M, Geisser MS, Anderson KE, Caporaso NE, Le C, Abdullah SB, Hecht SS, Oken MM, Van Ness B. Interaction of CYP1B1, cigarette-smoke carcinogen metabolism, and lung cancer risk. Int J Mol Epidemiol Genet. 2010 Aug 5;1(4):295-309.
- Results publication: PubMed 19124507Church TR, Anderson KE, Caporaso NE, Geisser MS, Le CT, Zhang Y, Benoit AR, Carmella SG, Hecht SS. A prospectively measured serum biomarker for a tobacco-specific carcinogen and lung cancer in smokers. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):260-6. doi: 10.1158/1055-9965.EPI-08-0718.
- Results publication: PubMed 22536319Fang G, Haznadar M, Wang W, Yu H, Steinbach M, Church TR, Oetting WS, Van Ness B, Kumar V. High-order SNP combinations associated with complex diseases: efficient discovery, statistical power and functional interactions. PLoS One. 2012;7(4):e33531. doi: 10.1371/journal.pone.0033531. Epub 2012 Apr 19.
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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.
Timothy Church, Ph.D. principal investigator
University of Minnesota
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 Tobacco Use Disorder and Lung Cancer, run by University of Minnesota 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 1 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 23 Jan 2017. 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?
Lung cancer (time frame: Cumulative incidence). 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 NCT00218179, 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 23 Jan 2017.