Core-Biomarker Development Laboratory

核心生物标志物开发实验室

基本信息

批准号：
10696075
负责人：
Paul Christopher Boutros
金额：
$ 38.45万
依托单位：
EASTERN VIRGINIA MEDICAL SCHOOL
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：
2022-09-02 至 2027-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10696075
关键词：
Adoption Age Algorithms American Autopsy BRCA2 gene Behavior Benchmarking Biochemical Biological Assay Biological Markers Biopsy Cancer Etiology Cessation of life Classification Clinical Clinical Management DNA Repair Data Data Analyses Data Set Defect Detection Diagnosis Disease Distant Early Detection Research Network Early Diagnosis Early identification Ecosystem Exhibits Fostering Gene Expression Genetic Germ-Line Mutation Incidence Indolent Institution Laboratories Lesion Life Liquid substance Local Therapy Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of prostate Medical Care Costs MicroRNAs Modernization Molecular Molecular Profiling Monitor Morbidity - disease rate Neoplasm Metastasis Newly Diagnosed Nomograms Outcome Pathogenicity Pathologic Patients Performance Population Prostate Prostatic Neoplasms Proteins Proteomics Protocols documentation Publishing Quality of life Radiology Specialty Research Personnel Risk Site Skin Cancer Stratification Talents Tissues Tumor Tissue United States Urine Variant Virginia aging population biomarker development biomarker panel biomarker validation cancer diagnosis candidate marker cohort cost diagnostic biomarker disorder risk efficacy testing gene repair genetic testing improved innovation laboratory development lifetime risk male health men mutant new growth novel patient subsets predictive marker premature protein biomarkers proteogenomics risk stratification serum PSA standard of care synergism tool tumor urinary validation studies variant of unknown significance

Adoption Age Algorithms American Autopsy BRCA2 gene Behavior Benchmarking Biochemical Biological Assay Biological Markers Biopsy Cancer Etiology Cessation of life Classification Clinical Clinical Management DNA Repair Data Data Analyses Data Set Defect Detection Diagnosis Disease Distant Early Detection Research Network Early Diagnosis Early identification Ecosystem Exhibits Fostering Gene Expression Genetic Germ-Line Mutation Incidence Indolent Institution Laboratories Lesion Life Liquid substance Local Therapy Magnetic Resonance Imaging Malignant Neoplasms Malignant neoplasm of prostate Medical Care Costs MicroRNAs Modernization Molecular Molecular Profiling Monitor Morbidity - disease rate Neoplasm Metastasis Newly Diagnosed Nomograms Outcome Pathogenicity Pathologic Patients Performance Population Prostate Prostatic Neoplasms Proteins Proteomics Protocols documentation Publishing Quality of life Radiology Specialty Research Personnel Risk Site Skin Cancer Stratification Talents Tissues Tumor Tissue United States Urine Variant Virginia aging population biomarker development biomarker panel biomarker validation cancer diagnosis candidate marker cohort cost diagnostic biomarker disorder risk efficacy testing gene repair genetic testing improved innovation laboratory development lifetime risk male health men mutant new growth novel patient subsets predictive marker premature protein biomarkers proteogenomics risk stratification serum PSA standard of care synergism tool tumor urinary validation studies variant of unknown significance

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项目摘要

Project Summary The critical challenge in the clinical management of newly-diagnosed localized prostate cancer remains distinguishing indolent from aggressive and life-threatening cancers. Biomarkers are urgently needed to identify those patients who harbor aggressive disease and will derive benefit from definitive treatment. We therefore, propose to apply complimentary proteogenomic-based discovery approaches to identify and then validate molecular features in prostate proximal fluids and tumor tissues that will be utilized in accurate early detection of aggressive forms of prostate cancer and improve disease risk stratification. The intended use of these biomarkers will be the early identification of men at risk for grade progression and improved risk- stratification for them. We have three biomarker development laboratory aims: 1) Validate our existing urine-based biomarkers for grade progression in a ProBE-compliant study selected from our own cohorts and the EDRN GU upgrading study. 2) Develop and validate urine and tissue-based biomarkers for the risk-stratification of MRI “invisible” high-grade lesions. 3) Develop and validate biomarkers to sub-stratify risk associated with deleterious germline BRCA2 variants. Our biomarker reference laboratory will develop and validate targeted clinically robust assays for multi-protein biomarkers panels. We will also develop decision algorithms that are cross-referenced for statistical rigor and benchmarked for optimal clinical performance. In addition to these BCC activities, we will develop robust PRM-MS assays and statistically rigorous decision tools for other EDRN BCCs and CVCs. Taken together, our EDRN biomarker characterization center will be a core part of the the EDRN ecosystem. We will continue to actively participate in trans-Network activities, and to share patient cohorts, protocols, datasets and analysis approaches and expertise. We will supplement these activities by focusing on promoting the growth of new and diverse talent in biomarker development through fostering junior investigator involvement across the full spectrum of biomarker development.

项目摘要新诊断的局部前列腺癌的临床管理中的关键挑战仍然存在区分懒惰和侵略性和威胁生命的癌症。迫切需要生物标志物确定那些怀有侵略性疾病并将从确定治疗中获得益处的患者。我们因此，提出了采用免费的基于蛋白质组的方法来识别并验证前列腺近端流体和肿瘤时序的分子特征，这些特征将在精确的早期中使用检测前列腺癌的侵略性形式并改善疾病风险分层。预期的用途这些生物标志物将是对有年级进展风险的男性的早期确定，并改善了风险 - 他们的分层。我们有三个生物标志物开发实验室目的：1）验证我们现有的基于尿液的生物标志物的从我们自己的同伙和EDRN GU升级的一项符合调查的研究中的年级进步学习。 2）开发和验证尿液和基于组织的生物标志物用于MRI“不可见”的风险分层高级病变。 3）开发和验证生物标志物以将与有害的风险相关种系BRCA2变体。我们的生物标志物参考实验室将开发并验证针对多蛋白的临床强大测定生物标志物面板。我们还将开发出针对严格统计严格的交叉引用的决策算法基准测试以获得最佳的临床性能。除了这些BCC活动外，我们还将发展强大针对其他EDRN BCC和CVCS的PRM-MS分析和统计严格的决策工具。综上所述，我们的EDRN生物标志物表征中心将是EDRN生态系统的核心部分。我们将继续积极参与跨网络活动，并分享患者同伙，协议，数据集和分析方法和专业知识。我们将通过关注这些活动来补充这些活动通过培养初级调查员来促进生物标志物开发中新的和多样的人才的增长参与生物标志物发展的全部范围。