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加入--为了评估用于临床决策的标记和分析，需要大量的临床注释样本，但通常不可能预测研究界的具体需求。为所有可能的不同需求建立样本库是非常昂贵的。癌症诊断计划(CDP)寻求测试对等信息学系统，以根据需要(即时)从社区卫生保健环境中定位和检索样本以及相关的临床和结果数据。有一个系统已经被证明在学术环境中有效，但更多的标本被存放在社区环境中。此外，健康维护机构一般都有住院和门诊记录，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正在支持一项计划，该计划旨在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个地点进行测试，地点显示高质量的、适合分子标记研究的存档病理标本；并拥有与这些标本相关联的计算机医疗记录系统。该计划最初将在当地现场测试和调整他们之前开发的去身份识别协议，评估其在更多案件中的性能。将构建测试检索查询，以包括识别病理报告中的样本以及与当地临床和结果数据库的链接。连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适当使用Study和当地人员对数据和病理块进行手动检查来进行。 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)。TMA将被乳腺癌研究人员用来开发和验证预后和预测性诊断生物标记物。来自不同地理区域具有5-10年临床随访数据的患者群体中的浸润性乳腺癌和DCIS病理病例的档案，将被用于设计具有内在统计学意义的预后和进展TMA。与每个病例(患者)相关的临床和结果数据字段包括：组织诊断、人口统计数据、疾病程度、治疗、随访、复发、存活率和生命状态。每个TMA需要数百例乳腺癌病例，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块，从块中切割切片，执行QA/QC，并在切片上标记用于取芯和构建TMA的适当区域。还需要进行重要的质量保证/质量控制，以确保与TMA中使用的标本相关的临床数据是完整和准确的。这一努力的最终结果将是提供质量有保证的肿瘤块，带有标记的载玻片和完整准确的数据。 校准慢性粒细胞白血病的BCR-ABL检测-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)的bcr-abl检测的接受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与其他实验室直接比较。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这种检测。没有常用的校准器来标准化化验。CDP正在支持这一项目，以评估统一RNA校准器的使用是否提高了这一检测的标准化。研究地点必须有CLIA认证的实验室，该实验室根据CLIA认证的实验室程序和方案常规进行BCR-ABL检测，NCI将提供特别准备的样品，包括一些复制品和校准器。