NCT00598143|Completed
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Sponsor study identifier
observational
45
1 country
1
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2008
Actual (reported)January 18, 2008
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.
conclusion of study
Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M.
conclusion of study
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.
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.
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.
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.
MSKCC clinics
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Saliva Samples
Jay Boyle, MD
Memorial Sloan Kettering Cancer Center
45 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2008
First Posted
January 18, 2008
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of NicVAX in Smokers Who Want to Quit Smoking
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
May 28, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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