Blood-Based Testing for Advanced Adenoma

项目概要/摘要 我们的临床验证中心（CVC）的目标是推进和验证基于血液的结直肠癌检测。 晚期腺瘤尽管基于血液的侵袭性结直肠癌检测正在取得进展， 公司追求的产品，血液为基础的测试，以检测先进的腺瘤的能力， 最接近浸润性癌症的恶性病变，是不确定的。为了最佳地影响结直肠癌的发病率， 基于血液的生物标志物不能仅仅检测癌症，它们还应该有足够的灵敏度来识别 晚期腺瘤患者。对于我们的CVC，我们组织和组装了一个高技能的网络， 临床中心，包括重点关注少数民族人群，前瞻性地收集特征良好， 在接受前，从大量患有晚期腺瘤的受试者中采集高质量的血液样本， 息肉切除术和连续息肉切除术后。从同一个临床中心，我们将收集血液样本 从控制对象。将使用标准方案采集和处理标本，并提供相关 将采集人口统计学和临床变量，以促进生物标志物验证研究。我们特别 我将使用这些特征鲜明的标本来验证我们关于原始创新技术实用性的数据 用于晚期腺瘤的分子检测，包括RealSeqS与定制机器的组合 学习算法，如SignaL。我们提出两个具体目标。在具体目标1中，我们将进行一个阶段 2项病例对照研究，以验证我们用于晚期腺瘤检测的新方法。我们将前瞻性地 招募晚期腺瘤患者（N=400）和部位特异性对照受试者（N=400）， 案件主体。在具体目标2中，我们将使用系统收集的系列血液样本， 从我们的病例受试者息肉切除术，以确定我们的新的分子检测技术是否可以 用于预测复发的可能性，并可能指导监测结肠镜检查。先进 腺瘤是非侵入性结直肠癌筛查的重要前沿，我们的CVC是 配备先进的血液检测先进的腺瘤。

PROJECT SUMMARY/ABSTRACT The goal of our Clinical Validation Center (CVC) is to advance and validate blood-based detection of colorectal advanced adenoma. Whereas blood-based testing for invasive colorectal cancer is progressing, with multiple companies pursuing products, the ability of blood-based testing to detect advanced adenomas, the pre- malignant lesions closest to invasive cancer, is uncertain. To optimally impact colorectal cancer incidence, blood-based biomarkers cannot just detect cancer, they should also have sufficient sensitivity to identify subjects with advanced adenomas. For our CVC, we organized and assembled a network of highly skilled clinical centers including a focus on minority populations, to prospectively collect well-characterized, high- quality blood specimens from a large number of subjects with advanced adenoma prior to undergoing polypectomy and serially post-polypectomy. From the same clinical centers, we will collect blood specimens from control subjects. Specimens will be collected and processed using standard protocols, and relevant demographic and clinical variables will be captured to facilitate biomarker validation studies. Specifically, we will use these well-characterized specimens to validate our data on the utility of original, innovative techniques for molecular detection of advanced adenomas including RealSeqS in combination with custom machine learning algorithms such as SignaL. We propose two Specific Aims. In Specific Aim 1, we will conduct a phase 2 case-control study to validate our novel methods for advanced adenoma detection. We will prospectively recruit patients with advanced adenoma (N=400) and site-specific control subjects (N=400) for comparison to the case subjects. In Specific Aim 2, we will utilize serial blood specimens systematically collected post- polypectomy from our case subjects to determine whether our novel molecular detection techniques can be used to predict likelihood of recurrence and potentially guide surveillance colonoscopy exams. Advanced adenomas are the important, next frontier in non-invasive colorectal cancer screening, and our CVC is equipped to profoundly advance blood-based detection of advanced adenoma.