Biomarkers of Molecular Risk in Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older;
- •>5 packyear history of smoking;
- •Ability to understand and sign informed consent.
- •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.
排除标准
- •Diagnosis of any cancer in the preceding twelve months; (excluding non melanoma skin cancer).
- •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
结局指标
主要结局
Estimate accrual rates and smokers' willingness to provide saliva for cancer risk assessment.
时间窗: conclusion of study
次要结局
- Evaluate the effect of smoking reduction and/or cessation on levels of urinary PGE-M.(conclusion of study)