DCTD Cancer Diagnosis

DCTD癌症诊断

• 批准号: 7789126
• 负责人: LARRY ARTHUR
• 金额: $ 100万
• 依托单位: SCIENCE APPLICATIONS INTERNATIONAL CORP
• 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/7789126
• 关键词: DCTD; Cancer; Diagnosis

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.

用于分子标志物研究的临床注释病理学标本的登记-需要大量临床注释标本来评价用于临床决策的标志物和测定，但通常不可能预测研究团体的特定需求。为所有不同的可能需要建立标本库是非常昂贵的。癌症诊断计划（CDP）旨在测试点对点信息系统，以根据需要（及时）从社区卫生保健机构定位和检索标本和相关临床和结果数据。一个系统的存在，已被证明是在学术环境中工作，但更多的标本被安置在社区环境中。此外，健康维护组织通常有住院和门诊记录，这可以提供比肿瘤登记中包含的更完整的治疗和复发信息。CDP正在支持一个项目，开发和测试一个开源的点对点计算机程序，以识别临床和医院环境中的病理标本和相关的临床和结果数据。该计划将在CDP从癌症研究网络（由NCI资助）成员中选择的2-3个研究中心进行测试，这些研究中心显示出良好的质量，适合分子标记研究的存档病理标本;并具有与标本相关联的计算机化病历系统。该计划最初将在当地测试和调整他们之前开发的去识别协议，评估其在越来越多的病例上的性能。将构建测试检索查询，以包括从病理学报告中识别标本并链接到当地临床和结局数据库。连续查询将越来越复杂，包括尽可能多的此类数据库。将由研究和当地工作人员（如适用）通过手动检查数据和病理学块来评价查询结果。 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构建统计设计的组织微阵列（TMA）。乳腺癌研究者将使用TMA来开发和验证预后和预测性诊断生物标志物。来自不同地理区域患者人群的存档、注释良好的浸润性乳腺癌和DCIS病理学病例以及5-10年的临床随访数据将用于设计具有内在统计学显著性的预后和进展TMA。与每个病例（患者）相关的临床和结局数据字段包括：组织学诊断、人口统计学数据、疾病程度、治疗、随访、复发、生存和生命状态。每个TMA都需要数百个乳腺癌病例，并且需要从更大的集合中选择，以避免偏见。委员会认证的病理学家需要选择病理组织块，从组织块上切下切片，进行QA/QC，并在切片上标记适当区域，以进行取芯和构建TMA。还需要进行重要的QA/QC，以确保与TMA中使用的标本相关的临床数据完整且准确。这一努力的最终结果将是交付质量有保证的肿瘤块与标记的幻灯片和完整和准确的数据。 CML BCR-ABL检测试剂盒的校准-癌症诊断计划（CDP）支持临床实践中分子诊断的开发和评估。临床医生对慢性粒细胞白血病（CML）BCR-ABL检测的接受程度受到美国实验室缺乏标准化的限制。该检测使用定量RT-PCR，尽管是在CLIA认证的实验室进行的，但一个实验室的结果不能直接与另一个实验室进行比较。目前，许多美国实验室使用不同的方案和不同的对照基因进行这种测定。没有常用的校准品来标准化测定。CDP正在支持该项目，以评估使用统一的RNA校准品是否可以提高该检测试剂盒的标准化。研究中心必须有一个CLIA认证的实验室，根据其CLIA认证的实验室程序和方案常规进行BCR-ABL检测，NCI将提供专门制备的样本，包括一些副本，并将提供校准品。