DCTD Cancer Diagnosis

DCTD癌症诊断

• 批准号: 8654755
• 负责人: DAVID HEIMBROOK
• 金额: $ 1460.76万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-26 至 2018-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8654755
• 关键词: American; Archives; Area; Biological Assay; Biological Markers; Breast Carcinoma; Calibration; Cancer Research Network; Chronic Myeloid Leukemia; Clinical; Clinical Data; Clinics and Hospitals; Collection; Communities; Community Healthcare; Complex; Computerized Medical Records Systems; Data; Databases; Development; Diagnosis; Diagnostic; Disease; Evaluation; Funding; Genes; Geographic Locations; Health Maintenance Organizations; Housing; Human Resources; Informatics; Inpatients; Laboratories; Laboratory Procedures; Link; Manuals; Molecular; Noninfiltrating Intraductal Carcinoma; Outcome; Outpatients; Pathologic; Pathologist; Pathology; Pathology Report; Patients; Performance; Protocols documentation; RNA; Records; Recurrence; Research; Research Personnel; Retrieval; Reverse Transcriptase Polymerase Chain Reaction; Sampling; Site; Slide; Specimen; Standardization; System; Testing; Time; Tissue Microarray; Tissues; Vital Status; Work; base; bcr-abl Fusion Proteins; cancer diagnosis; clinical decision-making; clinical practice; community setting; computer program; design; follow-up; improved; malignant breast neoplasm; member; molecular marker; open source; patient population; peer; prognostic; programs; tumor; tumor registry

Accession of Clinically Annotated Pathology Specimens for Molecular Marker Research - Large numbers of clinically annotated specimens are required for the evaluation of markers and assays for clinical decision-making, but it is generally not possible to anticipate the specific needs of the research community. It is very costly to set up specimen banks for all the different possible needs. The Cancer Diagnosis Program (CDP) seeks to test a peer-to-peer informatics system to locate and retrieve specimens and pertinent clinical and outcome data on an as needed (just-in-time) basis from community health care settings. A system exists that has been shown to work in an academic setting, but much larger numbers of specimens are housed in the community setting. In addition Health Maintenance Organizations generally have both inpatient and outpatient records, and this can provide more complete treatment and recurrence information than that contained in tumor registries. CDP is supporting a program to develop and test an open-source, peer-to-peer computer program to identify pathologic specimens and associated clinical and outcome data in clinic and hospital settings. This program will be tested in 2-3 sites selected by CDP from members of the Cancer Research Network (funded by the NCI), in sites showing good quality, archived pathologic specimens suitable for molecular marker studies; and to have computerized medical record systems that are linked to the specimens. This program will initially test and adapt their previously developed de-identification protocol at the local sites, evaluating its performance on ever larger numbers of cases. Test retrieval queries will be constructed to include the identification of specimens from pathology reports and linkage to local clinical and outcome databases. Successive queries will be increasingly complex, including as many such databases as possible. Evaluation of the query results will be by manual inspection of data and pathology blocks using study and local personnel as appropriate. Tissue Microarrays - The Cancer Diagnosis Program (CDP) supports construction of statistically designed Tissue Microarrays (TMAs) using breast cancer tissue and clinical data. The TMAs will be used by breast cancer investigators to develop and validate prognostic and predictive diagnostic biomarkers. Archival, well annotated invasive breast carcinoma and DCIS pathology cases from the patient population in diverse geographic areas with 5-10 years of clinical follow data will be used for designing prognostic and progression TMAs with built in statistical significance. Clinical and outcome data fields associated with each case (patient) include: histological diagnosis, demographic data, extent of disease, treatment, follow-up, recurrence, survival and vital status. Each TMA requires several hundred breast cancer cases and needs to be selected from a much larger collection to avoid biases. Board certified pathologists need to select pathology blocks, cut slides from the blocks, perform QA/QC and mark the appropriate areas on the slides for coring and construction of the TMAs. Significant QA/QC also needs to be performed to assure that the clinical data associated with the specimens used in the TMAs is complete and accurate. The end results of this effort will be the delivery of quality assured tumor blocks with marked slides and complete and accurate data. Calibration of the BCR-ABL Assay for CML - The Cancer Diagnosis Program (CDP) supports the development and evaluation of molecular diagnostics for clinical practice. Acceptance by clinicians of the BCR-ABL assay for Chronic Myelogenous Leukemia (CML) is limited by the lack of standardization among the American laboratories that perform the assay. The assay uses quantitative RT-PCR, and despite being performed in CLIA-certified laboratories, one laboratory's results cannot be directly compared to anothers. Currently many American laboratories perform this assay using different protocols and different control genes. There are no commonly used calibrators to standardize the assay. The CDP is supporting this project to assess whether use of a uniform RNA calibrator improves standardization of this assay. The study sites must have a CLIA-certified laboratory that routinely performs the BCR-ABL assay according to their CLIA certified laboratory procedures and protocols, and the NCI will provide specially prepared samples including some duplicates and will provide calibrators.

用于分子标记研究的临床注释病理标本的登录 - 对临床决策的评估和测定法需要大量临床注释的标本，但通常不可能预期研究社区的特定需求。为所有不同可能的需求设置标本库是非常昂贵的。癌症诊断计划（CDP）试图测试一个点对点信息学系统，以在需要（及时）（即时）的基础（即及时）从社区保健环境中找到和检索相关的临床和结果数据。存在已显示在学术环境中的系统，但是在社区环境中容纳了大量标本。此外，健康维护组织通常具有住院和门诊记录，这可以提供比肿瘤注册处所包含的更完整的治疗和复发信息。 CDP支​​持一项计划，以开发和测试开源，点对点计算机程序，以识别诊所和医院环境中的病理标本以及相关的临床和结果数据。该程序将在CDP从癌症研究网络成员（由NCI资助）中选择的2-3个地点进行测试，并在显示出适合分子标记研究的质量高质量，存档的病理标本中；并具有与标本相关的计算机化病历系统。该程序最初将测试并调整其先前开发的在本地站点的识别协议，从而评估其在大量案例上的性能。将构建测试检索查询，包括从病理报告中识别标本以及与局部临床和结果数据库的联系。连续的查询将变得越来越复杂，包括尽可能多的数据库。对查询结果的评估将是通过使用研究和当地人员的手动检查数据和病理块。 组织微阵列 - 癌症诊断计划（CDP）支持使用乳腺癌组织和临床数据统计设计的组织微阵列（TMA）的构建。乳腺癌研究人员将使用TMA来开发和验证预后和预测性诊断生物标志物。档案，注释良好的侵入性乳腺癌和DCIS病理病例来自不同地理区域的患者人群，临床范围为5 - 10年的临床遵循数据将用于设计具有统计学意义的预后和进展TMA。与每种情况相关的临床和结果数据领域（患者）包括：组织学诊断，人口统计数据，疾病程度，治疗，随访，复发，生存和生命状况。每个TMA都需要数百个乳腺癌病例，需要从更大的收集中选择以避免偏见。董事会认证的病理学家需要选择病理块，从块中切下幻灯片，执行QA/QC，并在幻灯片上标记适合TMA的幻灯片的适当区域。还需要执行重要的QA/QC，以确保与TMA中使用的标本相关的临床数据是完整而准确的。这项工作的最终结果将是通过明显的幻灯片和完整而准确的数据提供质量保证的肿瘤块。 BCR -ABL测定CML的校准 - 癌症诊断计划（CDP）支持分子诊断的临床实践的开发和评估。 BCR-ABL测定法对慢性骨髓性白血病（CML）的接受程度受到执行该测定法的美国实验室缺乏标准化的限制。该测定法使用定量RT-PCR，尽管在CLIA认证的实验室进行了，但一个实验室的结果无法直接与Anothers进行比较。目前，许多美国实验室使用不同的方案和不同的控制基因进行此测定。没有常用的校准器来标准化测定。 CDP支​​持该项目，以评估使用均匀的RNA校准器是否可以改善该测定法的标准化。研究地点必须具有经过CLIA认证的实验室，该实验室根据其CLIA认证的实验室程序和协议通常执行BCR-ABL测定法，NCI将提供包括某些重复的特定样品，并将提供校准器。