Biomarkers of Molecular Risk in Smokers
|ClinicalTrials.gov Identifier: NCT00598143|
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment|
|Smoking Cessation||Behavioral: Vignette, questionnaires and Saliva Samples Behavioral: Urine Collection, Smoking cessation treatment|
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Biomarkers of Molecular Risk in Smokers|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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.
Behavioral: Vignette, 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.
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.
Behavioral: Urine 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.
- Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment. [ Time Frame: conclusion of study ]
- Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M. [ Time Frame: conclusion of study ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598143
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Jay Boyle, MD||Memorial Sloan Kettering Cancer Center|