Comparative effectiveness in genomic & personalized medicine for colon cancer

描述(由申请人提供)：近年来，基因组或其他分子测试已被推荐用于癌症治疗领域的临床实践。它们被用来识别高危个体、筛查和执行早期检测、识别预后标志物和指导治疗过程。我们提出了一个有重点的研究计划，将调查几种与结直肠癌相关的测试的比较有效性。这项拟议的研究是NCI资助的癌症研究网络(CRN)的几个成员网站和学术合作伙伴的合作。 我们的结直肠癌GPM综合研究计划将包括两个主要部分：1)通过证据合成和成本效益分析收集二次数据，2)通过原则验证研究收集主要数据，以检查有关结直肠癌个性化药物的问题。在原则验证研究中，我们将评估KRAS和林奇综合征基因检测在我们的卫生系统中的使用情况，并与未接受检测的患者群体进行比较，以衡量KRAS检测的有效性。我们还将进行患者和医生的访谈，以衡量与KRAS测试相关的心理社会问题，并帮助我们了解基因测试结果是如何用于决策的。 我们的结直肠癌研究计划将建立可应用于未来其他癌症相关基因或分子测试的经验、数据系统和方法，例如UGT1A1测试，或乳腺癌的Oncotype DX和CYP2D6测试。我们提出的相互交织的研究计划将为进行初级和次级数据收集的研究团队之间的协同提供机会。 公共卫生相关性：我们将研究与结肠癌相关的几种基因测试，这些测试可能有助于医生了解谁会患上结肠癌，以及一些患者应该接受什么治疗。我们将研究谁接受检测，基因检测结果如何帮助人们决定做什么，以及患者在检测时是否会有不同的健康结果。我们还将总结已经发表的研究，并分析有关使用这些测试的成本信息。

DESCRIPTION (Provided by the applicant): In recent years, genomic or other molecular tests have been recommended for clinical practice in the area of cancer treatment. They are used to identify individuals at high risk, screen and perform early detection, identify prognostic markers, and guide course of therapy. We propose a focused program of research that will investigate the comparative effectiveness of several tests related to colorectal cancer. The proposed study is a collaboration of several of the member sites of the NCI-funded Cancer Research Network (CRN) and academic partners. Our comprehensive research program in GPM for colorectal cancer will have two main components: 1) secondary data collection through evidence synthesis and cost-effectiveness analysis, and 2) primary data collection through a proof-of-principle study to examine questions about personalized medicine for colorectal cancer. In the proof-of-principle study, we will evaluate the utilization of KRAS and Lynch Syndrome genetic tests within our health systems, and measure the effectiveness of KRAS testing compared with a patient population that does not receive testing. We will also conduct patient and physician interviews to measure psychosocial issues related to KRAS testing, and to help us understand how the genetic test results are used to inform decisions. Our research program in colorectal cancer will build the experience, data systems, and methods that can apply to other cancer-related genetic or molecular tests in the future, such as UGT1A1 testing, or Oncotype DX and CYP2D6 testing for breast cancer. The interwoven research program that we propose will provide opportunities for synergy between teams of researchers conducting primary and secondary data collection. PUBLIC HEALTH RELEVANCE: We will study several genetic tests related to colon cancer that may help doctors understand who will get colon cancer and what therapies some patients should receive. We will study who gets tested, how the genetic test result helps people decide what to do, and whether patients have different health outcomes when they get tested. We will also summarize research that has already been published and analyze cost information about the use of these tests.