Biomarkers of Molecular Risk in Smokers
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Purpose
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 | Intervention |
|---|---|
|
Smoking Cessation |
Behavioral: Vignette, questionnaires and Saliva Samples Behavioral: Urine Collection, Smoking cessation treatment |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Biomarkers of Molecular Risk in Smokers |
- Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Saliva Samples
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group A
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.
|
|
Group B
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
MSKCC clinics
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00598143 History of Changes |
| Other Study ID Numbers: | 04-141 |
| Study First Received: | January 9, 2008 |
| Last Updated: | May 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on June 18, 2013