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).

ChromoLogic将与匹兹堡大学、维克森林大学、肉瘤肿瘤学和希望之城癌症中心以及Charles River-Laval的经验丰富的团队合作，计划和开展这些研究。具体而言，承包商计划验证ChromoLogic的miRNA面板以预测临床（肉瘤患者）中的中性粒细胞减少症，并获得FDA批准（第1阶段）;验证ChromoLogic的miRNA面板以预测临床（头颈癌患者）中的纤维化，并获得FDA批准（第1阶段）;并提交预测ARS（中性粒细胞减少症）和DEARE（纤维化）的面板的pre-EUA（第2阶段）。