Biomarkers of Molecular Risk in Smokers



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:February 2005
End Date:February 2014
Contact:Jay Boyle, MD
Phone:212-639-2906

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Doctors at MSKCC are doing this research study to see if smokers are interested in the idea
that genes might be markers of cancer risk, and to see if smokers would want to learn this
information about their risk if it were available.

Different versions of the gene called UGT1A7 are found in different people. Certain versions
of this gene can increase the risk of cancer in people. In this study, doctors will
determine the different types of UGT1A7 in smokers and find out whether smokers show good
interest and understanding. The information from this study will be used in future studies
to identify smokers at increased risk for cancer, and to help smokers quit.


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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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