IGF::OT::IGF SBIR Phase II: Topic 338 - Predictive Biomarkers of Adverse Reactions to Prostrate Cancer Radiotherapy

IGF::OT::IGF SBIR II 期：主题 338 - 前列腺癌放射治疗不良反应的预测生物标志物

• 批准号: 9576448
• 负责人: ELIZABETH PETERSON-ROTH
• 金额: $ 199.6万
• 依托单位: L2 DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-19 至 2019-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9576448
• 关键词: Advanced Development; Adverse effects; Adverse reactions; Biological Assay; Biological Markers; Cancer Patient; Clinical; Data; Goals; Injury; Malignant neoplasm of prostate; Morbidity - disease rate; Outcome; Patients; Phase; Prostate; Provider; Radiation Tolerance; Radiation therapy; Risk; Small Business Innovation Research Grant; Testing; adverse outcome; cancer radiation therapy; cohort; genetic information; predictive marker; preference; prototype; radiosensitive; rectal; treatment planning; urinary

The overall objective of this project is to advance the development of a clinically usefully multiplex assay to detect biomarkers of radio-sensitivity that will identify subsets of prostate cancer patients for which radiotherapy should be contraindicated. This assay will be capable of predicting the risk of developing adverse effects – principally urinary morbidity and rectal injury – resulting from radiotherapy treatment of prostate cancer. Our studies have identified SNPs in multiple cohorts that are strongly associated with adverse effects resulting from radiotherapy. The goal of the current project is to validate these SNPs in an independent cohort using a multiplex SNP assay. The technical objectives of this project are: (1) Evaluate the clinical outcome associations with all SNPs (p-value < 10-6 in Phase I) in an independent clinical patient set; (2) Expand the content of prototype multiplex assay to detect relevant SNPs discovered in Phase I; (3) Test the ability of the prototype assay to predict adverse outcomes to prostate radiotherapy; and, (4) Obtain quantitative and qualtitative data describing provider preferences for receiving and using genetic information in radiotherapy treatment planning.

该项目的总体目标是推进临床有用的多重检测方法的开发， 检测放射敏感性的生物标志物，其将识别前列腺癌患者的子集， 放疗是禁忌症。该试验将能够预测发展的风险， 放射治疗引起的不良反应-主要是泌尿系统疾病和直肠损伤， 前列腺癌我们的研究已经在多个队列中发现了SNP，这些SNP与 放疗引起的副作用。当前项目的目标是在一个 使用多重SNP测定的独立群组。本项目的技术目标是：（1）评估 在独立的临床患者中，临床结果与所有SNP相关（I期p值< 10-6） （2）扩展原型多重测定的内容以检测I期中发现的相关SNP;（3） 测试原型测定预测前列腺放射治疗的不良结果的能力;以及，（4）获得 描述提供者接收和使用遗传信息偏好的定量和定性数据 在放射治疗计划中。