Gene-Environmental Risk Assessment and CRC Screening

基因环境风险评估和CRC筛查

基本信息

批准号：
7655552
负责人：
DAVID S WEINBERG
金额：
$ 72.94万
依托单位：
FOX CHASE CANCER CENTER
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-08-15 至 2011-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7655552
关键词：
Address Adenomatous Polyposis Coli Adherence Adoption Adult Affect Age Anxiety Area Attitude Blood specimen Cancer Etiology Cessation of life Clinical Colon Carcinoma Colorectal Cancer Data Disclosure Disease Enrollment Environment Environmental Risk Factor Epidemiology Family Fecal occult blood Feedback Folate Future Gene Abnormality Gene Mutation General Population Genes Genetic Genetic Polymorphism Genetic Predisposition to Disease Genetic screening method Genotype Goals Guidelines Health Healthcare Human Incidence Individual Institutes Intention Intervention Studies Joints Knowledge Label Link Literature Mails Malignant Neoplasms Measurement Measures Methods Methylenetetrahydrofolate reductase (NADPH)Modeling Mutation Nurses Office Visits Onset of illness Outcome Study Participant Patients Persons Pilot Projects Population Predisposition Preventive Primary Health Care Process Provider Psychological Impact Randomized Recommendation Relative (related person)Research Risk Risk Assessment Risk Reduction Risk Reduction Behavior Role Screening for cancer Screening procedure Serum Serum Folate Level Stratification Subgroup Surveys Test Result Testing Time Training Treatment/Psychosocial Effects Upper arm Work base behavior change cancer prevention cancer risk clinical practice colorectal cancer prevention colorectal cancer screening folic acid metabolism gene environment interaction high risk improved indexing innovation interest malignant breast neoplasm molecular marker mortality motivated behavior novel primary outcome psychological distress psychosocial routine practice treatment as usual uptake

项目摘要

DESCRIPTION (provided by applicant): Genetic testing for cancer susceptibility is currently offered only to subgroups of the population at high risk for single gene disorders. However, for most common cancers, susceptibility results from the variable contributions of many genes usually influenced by environmental factors. Assessing genes (and their environmental modifiers) with moderate predictive power for disease is expected to become an integral part of healthcare. At-risk persons might be identified before disease onset and risk reduction practices recommended earlier. Little is known about the effect of providing this information to average risk persons on their adoption of risk reduction practices or its psychological impact. Colorectal cancer (CRC) prevention is a promising area to study this emerging role for genetic testing. Individualized gene and environmental risk (GERA) feedback represents a potentially innovative method to increase CRC screening compliance. In the proposed study, average risk individuals (n=1950) who are not adherent to screening will be randomly assigned to usual care (DC) or to GERA feedback based on an assessment of the participant's polymorphic version of the MTHFR gene and serum folate level (environment). Epidemiological data support links between MTHFR, folate and CRC. Participants randomized to GERA will be offered MTHFR genotyping and folate measurement. A trained nurse will discuss testing results (elevated v. average risk) and review their significance relative to CRC. The study has 4 specific aims:(1) to determine the impact of GERA v. DC on CRC screening rates; (2) to determine the impact of GERA v. DC on psychological distress; (3) to determine the impact of GERA v. DC on CRC knowledge and attitudes (e.g. perceived risk etc); and (4) to identify factors that moderate the impact of GERA feedback on CRC screening utilization. Psychosocial data will be collected at baseline, at the time of results disclosure, and 1 week and 6 months after the study office visit. This project will provide information about the effect of GERA on CRC screening participation. It may also be relevant information about how genetic testing for common healthcare conditions will ultimately be integrated into standard clinical practice.

描述（由申请人提供）：目前仅提供针对癌症易感性的基因检测，仅提供给单个基因疾病高风险的人群的亚组。但是，对于最常见的癌症而言，易感性是由许多基因的可变贡献产生的，通常受环境因素影响。用中等的疾病预测能力评估基因（及其环境修饰符）将成为医疗保健不可或缺的一部分。在疾病发作和降低风险习惯之前，可能会发现高危人士。关于将此信息提供给普通风险人员对降低风险惯例或心理影响的影响知之甚少。结直肠癌（CRC）预防是研究基因检测的新兴作用的有前途的领域。个性化的基因和环境风险（GERA）反馈代表了提高CRC筛查依从性的潜在创新方法。在拟议的研究中，根据参与者对参与者的多态性版本的MTHFR基因和血清叶酸水平（环境）的评估，将随机分配给不遵守筛查的平均风险个人（n = 1950）。流行病学数据支持MTHFR，叶酸和CRC之间的联系。随机分配给GERA的参与者将提供MTHFR基因分型和叶酸测量。训练有素的护士将讨论测试结果（升高v。平均风险），并审查其相对于CRC的意义。该研究具有4个具体目的：（1）确定GERA诉DC对CRC筛查率的影响；（2）确定Gera诉DC对心理困扰的影响；（3）确定GERA诉DC对CRC知识和态度的影响（例如，感知风险等）；（4）确定适应GERA反馈对CRC筛查利用率的影响的因素。心理社会数据将在基线，结果披露时以及研究办公室访问后的1周零6个月收集。该项目将提供有关GERA对CRC筛查参与的影响的信息。它也可能是有关如何最终将基因测试纳入标准临床实践中的相关信息。