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.

用于分子标记研究的临床注释病理标本的加入-临床决策需要大量的临床注释标本来评估标记物和检测方法，但通常不可能预测研究界的具体需求。建立标本库以满足所有可能的不同需求是非常昂贵的。癌症诊断项目（CDP）旨在测试一个点对点信息系统，以便根据需要（及时）从社区卫生保健机构定位和检索标本以及相关的临床和结果数据。存在一个系统，已被证明在学术环境中起作用，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处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，以在诊所和医院环境中识别病理标本以及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个站点进行测试，这些站点显示出良好的质量，适合分子标记研究的存档病理标本；并拥有与标本相关联的计算机化医疗记录系统。该计划将首先在当地站点测试和调整他们先前开发的去识别协议，评估其在越来越多的案例中的表现。将构建测试检索查询，以包括从病理报告中识别标本以及与当地临床和结果数据库的联系。后续查询将变得越来越复杂，包括尽可能多的此类数据库。查询结果的评估将通过人工检查数据和病理块，酌情使用研究人员和当地人员。