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.

为分子标​​记研究获取临床注释的病理标本 - 评估标记和分析以进行临床决策需要大量临床注释的标本，但通常不可能预测研究界的具体需求。为所有不同的可能需求建立样本库的成本非常高。癌症诊断计划 (CDP) 旨在测试点对点信息系统，以便根据需要（及时）从社区医疗保健机构查找和检索样本以及相关临床和结果数据。现有的系统已被证明可以在学术环境中发挥作用，但更多的标本被安置在社区环境中。此外，健康维护组织通常都有住院和门诊记录，这可以提供比肿瘤登记处包含的更完整的治疗和复发信息。 CDP 正在支持一项开发和测试开源点对点计算机程序的计划，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，这些地点显示出适合分子标记研究的高质量、存档的病理标本；并拥有与标本相连的计算机化医疗记录系统。该计划将首先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案例中的性能。将构建测试检索查询，包括从病理报告中识别标本以及与当地临床和结果数据库的链接。连续的查询将变得越来越复杂，包括尽可能多的此类数据库。查询结果的评估将酌情使用研究人员和当地人员通过手动检查数据和病理块来进行。 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)。乳腺癌研究人员将使用 TMA 来开发和验证预后和预测诊断生物标志物。来自不同地理区域的患者群体的存档、注释清楚的浸润性乳腺癌和 DCIS 病理病例以及 5-10 年的临床随访数据将用于设计具有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：组织学诊断、人口统计数据、疾病范围、治疗、随访、复发、生存和生命状态。每个 TMA 需要数百个乳腺癌病例，并且需要从更大的集合中进行选择以避免偏差。经过委员会认证的病理学家需要选择病理块、从块上切割载玻片、执行 QA/QC 并在载玻片上标记适当的区域以用于 TMA 的取芯和构建。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。这项工作的最终结果将是提供有质量保证的肿瘤块，并带有标记的载玻片和完整准确的数据。 CML 的 BCR-ABL 检测校准 - 癌症诊断计划 (CDP) 支持临床实践分子诊断的开发和评估。由于执行该检测的美国实验室缺乏标准化，临床医生对慢性粒细胞白血病 (CML) 的 BCR-ABL 检测的接受度受到限制。该检测使用定量 RT-PCR，尽管是在 CLIA 认证的实验室中进行，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控制基因进行这种测定。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 校准器是否可以提高该测定的标准化。研究地点必须拥有 CLIA 认证的实验室，根据其 CLIA 认证的实验室程序和协议定期进行 BCR-ABL 测定，并且 NCI 将提供专门准备的样品（包括一些重复样品）并提供校准品。