Smoking Cessation
Conditions
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.
Interventions
BEHAVIORALVignette, questionnaires and Saliva Samples
The short vignette discusses the health implications of potential molecular markers of cancer risk assessment. The questionnaire asks several multiple-choice questions to assess the participant's interest in and understanding of molecular risk assessment. Patients are instructed to swish with 10cc of Scope mouthwash and to expectorate into a sterile 50cc conical tube.
BEHAVIORALUrine Collection, Smoking cessation treatment
Single void urine specimens (approximately 50 ml) will be collected in pre-labeled specimen containers on a 3-monthly (±1 month) basis for 12 months. Standard evidence-based therapy for smoking cessation, including behavioral therapy and pharmacological therapy, is provided.
Sponsors
Weill Medical College of Cornell University
Vanderbilt University School of Medicine
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment. | conclusion of study |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M. | conclusion of study |
Countries
United States
Outcome results
None listed