Biomarkers of Molecular Risk in Smokers

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Vignette, questionnaires and Saliva Samples; Behavioral: Urine Collection, Smoking cessation treatment

• Registration Number: NCT00598143
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Vignette, questionnaires and Saliva Samples	Ten healthy smokers will provide a saliva sample used to genotype UGT1A7 and complete a questionnaire to assess understanding of and willingness to participate in molecular risk assessments.
Group B	Urine Collection, Smoking cessation treatment	Thirty smokers will receive standard smoking cessation therapy and provide urine specimens for PGE-M analysis at approximate 3-monthly intervals over one year. Self-reported smoking status and expired-air carbon monoxide (CO) will also be recorded at 3-monthly clinic visits.

Primary Outcome Measures

Name	Time	Method
Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.	conclusion of study

Secondary Outcome Measures

Name	Time	Method
Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M.	conclusion of study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States