Flow Cytometric Analysis of Benign and Malignant Tumors

良性和恶性肿瘤的流式细胞术分析

• 批准号: 7735388
• 负责人: Maryalice Stetler-Stevenson
• 金额: $ 101.06万
• 依托单位: DIVISION OF CLINICAL SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7735388
• 关键词: Acute leukemia; Address; Antibodies; Benign; Biological Assay; Biopsy; Blood; Body Fluids; Bone Marrow; CCR; Cell Surface Proteins; Cells; Cerebrospinal Fluid; Cerebrum; Characteristics; Chronic Lymphocytic Leukemia; Clinical; Clinical Protocols; Common Neoplasm; Communities; Consensus; Data Analyses; Data Reporting; Detection; Detection of Minimal Residual Disease; Development; Diagnosis; Diagnostic; Diagnostic tests; Disease; Education; Eligibility Determination; Enrollment; Evaluation; Event; Family; Fine needle aspiration biopsy; Flow Cytometry; Goals; Gold; Guidelines; Hematologist; Immunophenotyping; Institutes; Institution; International; Laboratories; Laboratory Procedures; Laboratory Scientists; Lymphoma; Malignant - descriptor; Malignant Neoplasms; Measurement; Medical; Medical Staff; Methodology; Monitor; Neoplasms; Numbers; Patient Care; Patients; Process; Protocols documentation; Publishing; Recommendation; Residual state; Signs and Symptoms; Standardization; Standards of Weights and Measures; Structure; System; Techniques; Testing; Therapeutic; Time; Tissues; Training; Training and Education; United States; United States National Institutes of Health; Validation; base; cancer cell; improved; leukemia; leukemia/lymphoma; medical specialties; neoplastic; neoplastic cell; outcome forecast; response; symposium

The Flow Cytometry Unit provides extensive support for NCI clinical protocols by providing diagnostic testing for leukemia and lymphoma in patient either on NCI clinical protocols or undergoing testing to determine eligibility for said protocols. The Flow Cytometry Unit provides clinical flow cytometric evaluation of blood, bone marrow, fine needle aspirates, tissue biopsies and body fluids for hematolymphoid neoplasia in NCI patients. The majority of flow cytometric testing performed by the Flow Cytometry Unit involves detection of minimal residual disease (patients are status post therapy at outside institution prior to enrollment on NCI protocol) and measurement of specific tumor cell characteristics mandated by various clinical protocols. Significant effort in the unit is devoted to delivery of numerous unique protocol mandated assays that are not offered by commercial laboratories. The Flow Cytometry Unit is also actively engaged in education of the NIH staff and medical community at large in the proper utility of flow cytometry in medical practice. The utility of flow cytometric analysis in leukemia and lymphoma gained acceptance in the late 1980s. Since that time there has been growing concern among practitioners in the field of clinical flow cytometry about inconsistent practices as well as deficiencies in standardization and validation and its possible impact on patient care. To address this issue a group of U.S. and Canadian hematopathologists, hematologists and laboratory scientists met in Bethesda, MD from November 16-17, 1995 to develop the U.S.-Canadian Consensus Recommendations on the Immunophenotypic Analysis of Hematologic Neoplasia by Flow Cytometry. The consensus document produced provided guidance on standardization and validation of laboratory procedures, data analysis and interpretation and data reporting. Guidelines were also provided on medical indications for testing. Although consensus could not be reached at that time on the number or combination of antibodies utilized in flow cytometric evaluation of leukemia or lymphoma, strategies were provided for the selection of antibodies and lists of markers useful in identification of acute leukemias and lymphoproliferative processes were provided. Recently there was growing recognition of the need to set standards of training and education for practitioners in the field of flow cytometry, including technologists, interpreters and laboratory directors. It was also realized that the previous guidelines on medical indications for flow cytometric testing were no longer practical and that new guidelines on medical indications for flow cytometric analysis that are based upon clinical signs and symptoms suggestive of hematolymphoid neoplasia are needed in the field. Similarly, guidelines on antibody panels recommended for patients presenting with specific signs and symptoms are desirable. To address these issues the Flow Cytometry Unit, CCR, NCI, NIH organized the 2006 Bethesda International Consensus Conference on Flow Cytometric Immunophenotyping of Hematolymphoid Neoplasia. During this conference the important issues and goals were identified and a structure defined to achieve the identified goals. The final consensus recommendations on training, medical indications and antibody panels generated by this process were published in September 2007. A new consensus process in underway to determine optimal diagnostic antibody panels for various disease processes. The flow cytometry Unit participated in an international consensus group determining optimal methodology for diagnostic evaluation of cerebral spinal fluid for hematolymphoid neoplasia. The results on this consensus process have recently been published. The Flow Cytometry Unit, CCR, NCI, NIH has been instrumental in producing the regulatory document on flow cytometric immunophenotyping of lymphoma and leukemia, Clinical and Laboratory Standards Institute. Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline-Second Edition. CLSI document H43-A2 . This guideline will be used as the gold standard when laboratories performing flow cytometric analysis of hematolymphoid malignancies in the United States are inspected by CLIA/CAP. It provides detailed technical guidelines for laboratory procedures involved in flow cytometric testing of hematolymphoid neoplasia. The Flow Cytometry Unit has studied the immunophenotypic characteristics of familial and sporadic chronic lymphocytic leukemia. Familial chronic lymphocytic leukemia (CLL) families are being studied because they potentially provide a unique opportunity to study the development of CLL, a common neoplasm. We have studied the immunophenotypic profiles of patients with sporadic CLL and with familial CLL and found significant differences between the two groups. Furthermore, the association of prognosis with the cell surface protein profile differs between familial and sporadic CLL.

流式细胞仪为NCI临床方案提供广泛的支持，为NCI临床方案的白血病和淋巴瘤患者提供诊断测试，无论是在NCI临床方案中还是在进行测试以确定是否符合上述方案。流式细胞术单元为NCI患者的血液、骨髓、细针抽吸、组织活检和体液提供临床流式细胞术评估。由流式细胞仪进行的大多数流式细胞仪检测涉及微小残留疾病的检测（患者在NCI方案入组前在外部机构治疗后的状态）和各种临床方案规定的特定肿瘤细胞特征的测量。该单位的重大努力致力于提供商业实验室不提供的许多独特的协议规定的分析。流式细胞术组还积极参与NIH工作人员和医学界在医疗实践中流式细胞术的适当效用的教育。流式细胞分析在白血病和淋巴瘤中的应用在20世纪80年代末获得认可。从那时起，临床流式细胞术领域的从业者越来越关注不一致的实践以及标准化和验证方面的缺陷及其对患者护理的可能影响。为了解决这个问题，一组美国和加拿大的血液病理学家、血液学家和实验室科学家于1995年11月16日至17日在马里兰州贝塞斯达会面，制定了美国和加拿大关于流式细胞术血液肿瘤免疫表型分析的共识建议。所产生的协商一致文件为实验室程序的标准化和验证、数据分析和解释以及数据报告提供了指导。还就检测的医学指征提供了准则。虽然当时在白血病或淋巴瘤的流式细胞术评估中使用的抗体的数量或组合方面尚未达成共识，但提供了选择抗体的策略，并提供了用于识别急性白血病和淋巴细胞增殖过程的标志物清单。最近，越来越多的人认识到需要为流式细胞术领域的从业人员（包括技术人员、口译员和实验室主任）制定培训和教育标准。人们还认识到，以前关于流式细胞术检测医学指征的指南已不再实用，该领域需要基于提示淋巴细胞瘤的临床体征和症状的流式细胞术分析医学指征的新指南。同样，推荐针对有特定体征和症状的患者的抗体检测指南也是可取的。为了解决这些问题，流式细胞术单位，CCR， NCI， NIH组织了2006年Bethesda国际共识会议，讨论了淋巴细胞瘤的流式细胞术免疫表型。在这次会议期间，确定了重要问题和目标，并确定了实现确定目标的结构。2007年9月公布了这一进程产生的关于培训、医学指征和抗体小组的最终协商一致建议。一个新的共识过程正在进行中，以确定各种疾病过程的最佳诊断抗体面板。流式细胞术单位参加了一个国际共识小组，确定了诊断评价脑脊髓液对淋巴细胞瘤的最佳方法。这一协商一致进程的结果最近已发表。流式细胞术单位，CCR， NCI， NIH在生产淋巴瘤和白血病的流式细胞术免疫表型，临床和实验室标准研究所的监管文件中发挥了重要作用。肿瘤淋巴细胞临床流式细胞术分析批准指南-第二版。CLSI文档H43-A2。本指南将作为金标准，在美国进行血液淋巴细胞恶性肿瘤流式细胞分析的实验室接受CLIA/CAP的检查。它提供了详细的技术指南，实验室程序涉及到血淋巴瘤的流式细胞术检测。流式细胞仪研究了家族性和散发性慢性淋巴细胞白血病的免疫表型特征。家族性慢性淋巴细胞白血病（CLL）家族正在被研究，因为它们可能为研究CLL（一种常见的肿瘤）的发展提供了独特的机会。我们研究了散发性CLL和家族性CLL患者的免疫表型，发现两组之间存在显著差异。此外，家族性和散发性CLL患者的预后与细胞表面蛋白谱的关系不同。

项目成果

Minimal residual disease detection in hairy cell leukemia. Comparison of flow cytometric immunophenotyping with clonal analysis using consensus primer polymerase chain reaction for the heavy chain gene.

毛细胞白血病的微小残留病检测。

• DOI: 10.1309/g629-9513-nglc-ub1k
• 发表时间: 2003
• 期刊: American journal of clinical pathology
• 影响因子: 3.5
• 作者: Sausville,JustinE;Salloum,RitaG;Sorbara,Lynn;Kingma,DouglasW;Raffeld,Mark;Kreitman,RobertJ;Imus,PaulaD;Venzon,David;Stetler-Stevenson,Maryalice
• 通讯作者: Stetler-Stevenson,Maryalice

Clinical quantitative flow cytometry: "Identifying the optimal methods for clinical quantitative flow cytometry".

临床定量流式细胞术：“确定临床定量流式细胞术的最佳方法”。

• DOI: 10.1002/cyto.b.10053
• 发表时间: 2003
• 期刊: Cytometry. Part B, Clinical cytometry
• 作者: Marti,GeraldE;VogtJr,RobertF;Stetler-Stevenson,Maryalice
• 通讯作者: Stetler-Stevenson,Maryalice

Detection of malignant hematopoietic cells in cerebral spinal fluid previously diagnosed as atypical or suspicious.

检测先前诊断为非典型或可疑的脑脊液中的恶性造血细胞。

• DOI: 10.1002/cncr.21915
• 发表时间: 2006
• 期刊: Cancer
• 影响因子: 6.2
• 作者: Schinstine,Malcolm;Filie,ArmandoC;Wilson,Wyndham;Stetler-Stevenson,Maryalice;Abati,Andrea
• 通讯作者: Abati,Andrea