Breast Cancer Prediction Using Nipple Aspirate Fluid

使用乳头抽吸液预测乳腺癌

• 批准号: 7729677
• 负责人: EDWARD R SAUTER
• 金额: $ 15.55万
• 依托单位: UNIVERSITY OF NORTH DAKOTA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-20 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7729677
• 关键词: Antigens; Aspirate substance; Benign; Biological Markers; Biopsy; Breast; Breast Cancer Detection; Breast Cancer Early Detection; Cancer Center; Clinical; Collection; Cytology; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Enrollment; Evaluable Disease; Extracellular Fluid; Fibroblast Growth Factor 2; Funding; Goals; Image; Institutes; Institution; Invasive; Lesion; Link; Liquid substance; Malignant - descriptor; Malignant Neoplasms; Mammography; Measures; Missouri; Modeling; Molecular Diagnosis; Multicenter Trials; Nature; Needles; Nipples; Operative Surgical Procedures; Orosomucoid; Pain; Palpable; Phase; Plasminogen Activator Inhibitor 1; Plasminogen Inactivators; Postmenopause; Premenopause; Prostate-Specific Antigen; Proteins; Sampling; Schedule; Techniques; Universities; Urokinase; Woman; breast surgery; cancer risk; extracellular; malignant breast neoplasm; predictive modeling; prospective; success; tool; translational clinical trial

DESCRIPTION (provided by applicant): Currently available breast cancer screening tools such as mammography and breast examination miss 10-40% of early breast cancers and require an invasive diagnostic biopsy to institute therapy. We propose a prospective multicenter trial including Ellis Fischel Cancer Center/University of Missouri, Stanford University and The Royal Marsden Cancer Center. The goal of the trial is to develop a highly predictive, noninvasive breast cancer early detection model using breast nipple aspirate fluid (NAF) and clinical information collected from women scheduled for breast surgery. Our hope is that this model will ultimately minimize the need for invasive diagnostic needle and surgical biopsies. In Phase I of the funding period, we will (1) standardize and optimize the collection of NAF at the three participating institutions, and (2) identify the panel of extracellular biomarkers from the NAF samples analyzed which provides the maximum sensitivity in breast cancer detection. The extracellular markers to be analyzed (prostate-specific antigen, basic fibroblast growth factor, gross cystic disease fluid protein-15, alpha-1 acid glycoprotein, urinary plasminogen activator (uPA), uPA inhibitor (PAI-1), and the Thomas-Friedrichson antigens TF and Tn) have each been measured in and associated with breast cancer in NAF. We propose Milestones which set forth specific criteria to allow us to determine our success in Phase I and assess if we can proceed to Phase II. In Phase II we will (1) use the panel of NAF biomarkers identified in Phase I, along with NAF cytology and clinical biomarkers linked to breast cancer risk, to develop a highly predictive breast cancer detection model, and (2) determine the best breast cancer detection model for various subsets of subjects, including pre- and postmenopausal women and those presenting with or without a palpable breast mass.

描述（由申请人提供）：目前可用的乳腺癌筛查工具，例如乳房X线摄影和乳房检查，缺少10-40％的早期乳腺癌，需要进行侵入性的诊断活检才能进行治疗。我们提出了一项预期的多中心试验，包括埃利斯·费舍尔癌症中心/密苏里大学，斯坦福大学和皇家马斯登癌症中心。该试验的目的是使用乳腺乳头抽吸液（NAF）开发高度预测性的无创乳腺癌早期检测模型，并从计划进行乳房手术的女性中收集的临床信息。我们的希望是，该模型最终将最大程度地减少对侵入性诊断针和手术活检的需求。在资助期的第一阶段，我们将（1）在三个参与机构中标准化和优化NAF的收集，以及（2）从分析的NAF样品中确定细胞外生物标志物的小组，从而在乳腺癌检测中提供了最大的敏感性。待分析的细胞外标记（前列腺特异性抗原，碱性成纤维细胞生长因子，总囊性疾病液蛋白15，α-1酸糖蛋白，尿纤溶酶原激活剂（UPA），UPA抑制剂（PAI-1），以及与Thomas-Fridrichson抗原抗原和TF相关的NAF anf anf inf anf inf anf inf anf inf anf anf anf anf anf anf anf anf anf anf anf anf anf anf。我们提出的里程碑列出了特定的标准，使我们能够确定第一阶段的成功并评估是否可以继续第二阶段。在第二阶段，我们将使用（1）使用I阶段中确定的NAF生物标志物，以及与乳腺癌风险相关的NAF细胞学和临床生物标志物，开发高度预测性的乳腺癌检测模型，（2）确定对各种受试者的最佳乳腺癌检测模型，包括前后妇女以及与乳房的乳房和乳房那些人相比，或者不适合乳房，或者不适合乳房。