Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 10:32 AM
Study NCT ID:
NCT01092650
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2010-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The purpose of this research study is to better understand how people respond to cancer-causing chemicals in cigarette smoke. Some people are able to get rid of these chemicals as harmless agents while others suffer damage to their cells that can ultimately result in cancer. We hope to develop a better understanding of how we can identify the people who are in danger of getting cancer. Participants will complete questionnaires regarding their health and smoking history. We will take blood samples to look at genes which determine how the body breaks down some tobacco-related toxins. Participants will be given a small amount of liquid to drink, containing alcohol, water, and a compound called deuterated phenanthrene (DP), which is found in cigarette smoke and in the environment. Phenanthrene is non-toxic and does not cause cancer, but this compound is broken down by the body in the same way as cancer-causing agents. We will follow the pathway of this compound as it is broken down in the body.
Detailed Description:
Forty apparently healthy smokers and non smokers (20 male, 20 female) will be recruited by advertising in the Twin Cities area. This will be done by the Tobacco Use Research Center. They will be screened in a phone call, then invited to come in for an orientation session at which consent will be obtained. Pregnant smokers will be excluded. They will visit the clinic weekly for 2 months and once monthly for 4 months for a total of 6 months participation.
At each visit they will drink 5 ml of 50:50 ethanol:water containing 10 ug \[D10\]phenanthrene. They will then collect their 24h urine and return it to the clinic. The urine will be analyzed for \[D10\]phenanthrene tetraol. The goal of the study is to determine the longitudinal stability of the amount of \[D10\]phenanthrene-tetraol in urine.
At each visit they will drink 5 ml of 50:50 ethanol:water containing 10 ug \[D10\]phenanthrene. They will then collect their 24h urine and return it to the clinic. The urine will be analyzed for \[D10\]phenanthrene tetraol. The goal of the study is to determine the longitudinal stability of the amount of \[D10\]phenanthrene-tetraol in urine.
Study Oversight
Has Oversight DMC:
True
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?: