Blood-Based Testing for Advanced Adenoma

晚期腺瘤的血液检测

基本信息

批准号：
10703489
负责人：
ROBERT E. SCHOEN
金额：
$ 98.5万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-12 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10703489
关键词：
Adenomatous Polyps Aneuploidy Biological Assay Biological Markers Blood Blood Tests Blood specimen Cancer Detection Cancer Etiology Case/Control Studies Cell Proliferation Cessation of life Clinical Clinical Skills Collaborations Collection Colonoscopy Colorectal Colorectal Cancer Complement Custom DNA DNA Fragmentation Data Detection Early Detection Research Network Early Diagnosis Encapsulated Evaluation Evolution Excision Feces Genes Goals Incidence Industry Laboratories Lesion Malignant Neoplasms Methods Minority Groups Molecular Monitor Mutation Outcome Patient Recruitments Patients Pattern Performance Phase Polypectomy Polyps Population Process Proteins Protocols documentation Public Health Recurrence Recurrent disease Reproducibility Risk Risk Assessment Sampling Sensitivity and Specificity Signal Transduction Site Specimen Techniques Technology Testing United States Universities Validation adenoma biomarker validation blood-based biomarker cancer invasiveness cancer prevention clinical center colorectal cancer screening detection method follow-up frontier innovation innovative technologies interest machine learning algorithm methylation biomarker molecular marker mortality novel premalignant prevent prospective randomized trial screening success tumor DNA uptake validation studies

项目摘要

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.

项目摘要/摘要我们临床验证中心（CVC）的目标是进步和验证基于血直肠的检测晚期腺瘤。基于血液的侵入性结直肠癌的测试正在进行中，有多个追求产品的公司，基于血液的测试检测高级腺瘤的能力，最接近侵入性癌症的恶性病变尚不确定。为了最佳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到癌症，它们还应该具有足够的敏感性来识别具有晚期腺瘤的受试者。对于我们的CVC，我们组织并组建了一个高技能的网络临床中心包括关注少数族裔，以预期收集良好的，高的在接受高级腺瘤的大量受试者之前的优质血液标本多型切除术和串行后切除术。从同一临床中心，我们将收集血液标本来自控制对象。标本将使用标准协议收集和处理人口统计学和临床变量将被捕获以促进生物标志物验证研究。具体来说，我们将使用这些良好的标本来验证我们有关原始创新技术实用程序的数据用于分子检测高级腺瘤，包括REALSEQS与定制机器结合学习算法，例如信号。我们提出了两个具体目标。在特定目标1中，我们将进行一个阶段 2病例对照研究以验证我们的新方法用于晚期腺瘤检测。我们将前景患有晚期腺瘤（n = 400）和特定部位对照受试者（n = 400）的招募患者进行比较案件对象。在特定的目标2中，我们将系统地收集到序列的血液标本。我们病例受试者的多型切除术，以确定我们的新分子检测技术是否可以是用于预测复发的可能性和潜在的指导监视结肠镜检查检查。先进的腺瘤是非侵入性大肠癌筛查中的重要，下一个领域，我们的CVC是配备了深刻促进血液腺瘤的基于血液的检测。