Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218179
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2005-09-16
Brief Title:
Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Prostate Lung Colon and Ovarian Cancer PLCO Screen Trial
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50DA013333 | NIH | None | httpsreporternihgovquickSearchP50DA013333 |