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作为替代终点的免疫生物测定标准化

Standardization of immunobioassays as surrogate endpoints.

作者信息

Masood S

机构信息

University of Florida College of Medicine, Department of Pathology and Laboratory Medicine, Jacksonville 32209.

出版信息

J Cell Biochem Suppl. 1994;19:28-35.

PMID:7823602
Abstract

Despite centuries of scientific inquiry and medical effort, breast cancer remains one of the most dreaded human illnesses, emphasizing the need for prevention, early detection, and better management of these patients. Currently, newly recognized biomarkers are being examined as prognostic indicators to identify potentially aggressive cancers and to aid in planning treatment. Although the new prognostic factors are not yet firmly established, recent insights coupled with the availability of new biological markers have provided an opportunity to understand the initial genetic events leading to the development of breast cancer. Knowledge about those genetic events may provide opportunities for prophylactic intervention, improve our ability to predict breast cancer risk, and lead to strategies for early detection. Attention has focused on histomorphological changes and, to a lesser extent, cytomorphological changes in breast lesions associated with increased risk for subsequent breast cancer. However, the goal underlying the detection of early breast cancer is to distinguish patients who will develop breast cancer from those who will not. This task involves complex issues surrounding the selection, validation, quantitation, standardization, and population application of breast cancer biomarkers, and perhaps designing a protocol to control four major sources of cancer marker variability which may confound biomarker clinical application. These include biological and sampling diversity, variability of detection procedures, and validation against acknowledged disease endpoints. Immunocytochemistry has been applied extensively to assess the pattern of expression of different biomarkers in breast cancer. Immunocytochemical assays have permitted the localization of estrogen and progesterone receptors, oncogenes and tumor suppressor genes, growth factors, and other constituents at the cellular level, and also facilitated correlative analysis of morphology with specific expression of gene products.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

尽管经过了数百年的科学探究和医学努力,乳腺癌仍然是最令人恐惧的人类疾病之一,这凸显了对这些患者进行预防、早期检测和更好管理的必要性。目前,新发现的生物标志物正作为预后指标进行研究,以识别潜在的侵袭性癌症并辅助制定治疗方案。虽然新的预后因素尚未完全确立,但最近的见解以及新生物标志物的可得性为理解导致乳腺癌发生的初始基因事件提供了契机。了解这些基因事件可能为预防性干预提供机会,提高我们预测乳腺癌风险的能力,并催生早期检测策略。人们的注意力集中在乳腺病变的组织形态学变化上,在较小程度上也关注细胞形态学变化,这些变化与后续患乳腺癌风险增加相关。然而,早期乳腺癌检测的根本目标是区分哪些患者会患乳腺癌,哪些患者不会。这项任务涉及围绕乳腺癌生物标志物的选择、验证、定量、标准化和人群应用的复杂问题,或许还需要设计一个方案来控制可能混淆生物标志物临床应用的癌症标志物变异性的四个主要来源。这些来源包括生物学和采样多样性、检测程序的变异性以及针对公认疾病终点的验证。免疫细胞化学已被广泛应用于评估乳腺癌中不同生物标志物的表达模式。免疫细胞化学分析使得雌激素和孕激素受体、癌基因和抑癌基因、生长因子以及其他成分在细胞水平上得以定位,还促进了形态学与基因产物特异性表达的相关分析。(摘要截选至250词)

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