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• 批准号: 10937979
• 负责人: RALPH PARCHMENT
• 金额: $ 3347.25万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2028-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10937979
• 关键词: AML/MDS; Area; Authorization documentation; Biological Assay; Biological Markers; Categories; Characteristics; Clinical; Clinical Data; Clinical Protocols; Clinical Trials; Contracts; Data; Data Commons; Data Files; Diagnostic; Disease; Division of Cancer Treatment and Diagnosis; Eligibility Determination; Enrollment; Future; Generations; Genotype; Goals; Immune; Institute of Medicine (U.S.); Laboratories; Molecular Profiling; Molecular Target; National Clinical Trials Network; Oncogenic; Pathway interactions; Patients; Pharmaceutical Preparations; Phenotype; Physicians; Protocols documentation; Publications; Regulation; Relapse; Reporting; Reproducibility; Residual Neoplasm; Residual state; Resistance; Selection for Treatments; Site; Specimen; Structure; Testing; Therapeutic; Vendor; Work; biobank; biomarker identification; data access; data warehouse; leukemia; longitudinal analysis; predictive signature; profiles in patients; resistance mechanism; response; sample collection; treatment optimization; treatment response

The Division of Cancer Treatment and Diagnosis, NCI (DCTD) has embarked on a strategic initiative in its National Clinical Trials Network (NCTN) to define and discover new treatments for patients with AML/MDS. As described in a recent report from the Institute of Medicine ‘treatment for these patients has not changed in a substantive way in the last 40 years’ demonstrating that advances in this area are critically needed. The primary goal of this initiative is to optimize therapeutic strategies for patients with these diseases. This includes: • A master screening protocol that evaluates patients for assignment to clinical trials. • A data support structure that allows longitudinal analysis of sensitivity and resistance biomarkers in leukemia for discovery of new molecular targets • Deciphering clonal selection in minimal residual disease • Understanding mechanisms of resistance and response to therapy The long-term goals of the study are to: • Identify biomarkers with the potential to optimize therapy selection • Define molecular signatures that predict different response categories • Define phenotype/genotype characteristics of response/resistance that will be valid for diverse or specific classes of drugs with different mechanisms of action. • To identify targets in minimal residual disease (MRD), including targets in relapse and to identify new ways to eradicate MRD.

NCI癌症治疗和诊断部(DCTD)在其全国临床试验网络(NCTN)中启动了一项战略倡议，以确定和发现AML/MDS患者的新治疗方法。正如医学研究所最近的一份报告所描述的那样，过去40年来，对这些患者的治疗没有实质性的改变，这表明在这一领域亟需取得进展。 这一倡议的主要目标是优化这些疾病患者的治疗策略。 这包括： ·一种主要的筛查方案，评估分配给临床试验的患者。 ·数据支持结构，允许纵向分析白血病的敏感性和耐药性生物标记物，以发现新的分子靶点 ·破译微小残留病中的克隆选择 ·了解抵抗机制和对治疗的反应 这项研究的长期目标是： ·确定有可能优化治疗选择的生物标记物 ·定义预测不同响应类别的分子签名 ·确定对具有不同作用机制的不同或特定类别的药物有效的反应/耐药的表型/基因型特征。 ·确定微小残留病(MRD)的目标，包括复发的目标，并确定根除MRD的新方法。