MIDOS: A MICRORNA BIODOSIMETER

MIDOS：微型生物剂量计

• 批准号: 10932599
• 负责人: THERESA NGUYEN
• 金额: $ 159.9万
• 依托单位: CHROMOLOGIC, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10932599
• 关键词: Blinded; Cancer Center; Cities; Clinic; Clinical; Contractor; Documentation; Evaluation; Fibrosis; Gene Expression; Goals; Head and Neck Cancer; Laboratories; Late Effects; Malignant Neoplasms; Marketing; MicroRNAs; Neutropenia; Oncology; Patients; Phase; Radiation; Radiation Fibrosis; Radiation Injuries; Sampling; Sensitivity and Specificity; Testing; Translating; Universities; Validation; biodosimeter; circulating microRNA; experience; forest; head and neck cancer patient; meetings; microRNA biomarkers; predictive test; recruit; sample collection; sarcoma

ChromoLogic will team with the experienced groups at the University of Pittsburgh, Wake Forest University, Sarcoma Oncology and City of Hope Cancer Center, and Charles River-Laval to plan and carry out the studies. Specifically, the Contractor plans to validate ChromoLogic’s miRNA panel to predict neutropenia in the clinic (sarcoma patients), and obtain FDA approval (Phase 1); validate ChromoLogic’s miRNA panel to predict fibrosis in the clinic (head and neck cancer patients) and obtain FDA approval (Phase 1); and submit pre-EUA for panels to predict ARS (neutropenia) and DEARE (fibrosis) (Phase 2).

Shromologic将与匹兹堡大学，Wake Forest University，Sarcomogology和Hope Cancer Center Center和Charles River-Laval的经验丰富的团体合作，以计划和进行研究。具体而言，承包商计划验证色彩学的miRNA面板，以预测诊所（肉瘤患者）中中部性症，并获得FDA批准（第1阶段）；验证色彩学的miRNA面板以预测临床（头颈癌患者）的纤维化并获得FDA批准（第1阶段）；并提交欧洲前的eua，以预测ARS（中性粒细胞减少）和Deare（纤维化）（第2阶段）。