Clinical trial NCT00598143: Biomarkers of Molecular Risk in Smokers
Official title: Biomarkers of Molecular Risk in Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: Vanderbilt University School of Medicine
First posted: 2008-01-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.
timeFrame: conclusion of study
Secondary outcomes:
measure: Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jay Boyle, MD
role: PRINCIPAL_INVESTIGATOR
References: