Biomarkers of Molecular Risk in Smokers
18 Years
N/A
Both
Smoking Cessation
Trial Information
Biomarkers of Molecular Risk in Smokers
This study consists of two arms; both of which are observational studies of molecular
assessments of risk for tobacco related cancer. Arm A of the protocol is a pilot
crosssectional study that evaluates the feasibility of obtaining and testing a genetic
marker of cancer susceptibility (UGT1A7 polymorphisms) in smokers. It also explores smokers'
interest in and comprehension of genetic risk assessments as possible tools for increasing
motivation for smoking cessation. The second arm of this protocol, Arm B, is an
observational prospective evaluation of a putative noninvasive biomarker of tobacco smoke
exposure - urinary prostaglandin E-metabolite (PGE-M) - in smokers motivated to reduce
and/or cease smoking.
Inclusion Criteria:
- Arm A
- 18 years or older;
- >5 packyear history of smoking;
- Ability to understand and sign informed consent.
- Arm B
- 18 years or older;
- >10 packyear history of smoking;
- Intention to taper and/or quit smoking within 6 months
- Ability to understand and sign informed consent.
Exclusion Criteria:
- Arm A
- Diagnosis of any cancer in the preceding twelve months; (excluding non melanoma skin
cancer).
- Arm B
- Diagnosis of any cancer in the preceding twelve months; (excluding non melanoma skin
cancer).
- Use of any COX-2 inhibitor, steroid, or non-steroidal anti-inflammatory medication
(excluding cardioprotective aspirin > 81mg/d) within one week of urine collection
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.
Outcome Time Frame:
conclusion of study
Safety Issue:
No
Principal Investigator
Jay Boyle, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
04-141
NCT ID:
NCT00598143
Start Date:
February 2005
Completion Date:
February 2014
Related Keywords:
- Smoking Cessation
- Smoking
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
