多因子生物标志物应用于早期特异性诊断浆液性卵巢癌诊断

由于大多数患者是在晚期确诊，卵巢癌仍然是最致命的妇科恶性肿瘤。没有单一的生物标志物具有所需的灵敏度和特异性。

耶鲁大学医学院妇产科，哈佛大学布列根和妇女医院（Brigham and Women’s Hospital，BWH），丹娜法伯癌症研究院，约翰霍普金斯大学医学院西德尼Kimmel综合癌症中心等，联合开发了一组新的生物标志物，用于早期发现高级别浆液性卵巢癌。结果发表在最新一起妇产科肿瘤权威杂志：Gynecologic Oncology。 

临床研究设计：

1. 候选因子：12个：IL-1Ra, IL-6, Dkk-1, uPA, E-CAD, ErbB2, SLPI, HE4, CA125, LCN2,MSLN, and OPN

2. 研究对象： 172病人（有妇科良性病变，或高级别浆液性卵巢腺癌等)

3. 技术平台： Ella Simple Plex （ProteinSimple）

4. 结果：CA125, HE4, E-CAD, IL-6 四因子组成的panel具有特异性诊断浆液性卵巢癌的临床价值。     

a)      卵巢癌病人versus无肿瘤对照组：特异性100%，阳性预测价值100%，灵敏度 86.4%

b)      卵巢癌病人versus妇科良性疾病对照组：特异性100%，阳性预测价值100%，灵敏度 87.2%

c)      卵巢癌病人versus无妇科良性疾病对照组：特异性100%，阳性预测价值100%，灵敏度 98.4%

d)      早期浆液性卵巢癌 Versus无肿瘤对照组：特异性95.7%，阳性预测价值88.9%，灵敏度 84.2%  

文中，作者特别注明选择Ella simple plex进行本项研究的原因：

Our study is one such effort to identify a panel of multiple serum biomarkers which is not just sensitive and specific, but also time-efficient and cost-effective. Simple Plex™is a new multi-analyte immunoassay platform, which has been proven to have significant advantages over traditional approaches in terms of low volume requirements (2.5 to 25 μL), sensitivity, and reproducibility [34,35]. Simple Plex™ eliminates inconsistency in sample handling and  produces results in a short amount of time, thus providing results with minimal error and in timely fashion. Simplex Plex™ costs much less and would be more cost-efficient to analyze multiple biomarkers.

原文信息：

A novel multiple biomarker panel for the early detection of high-grade
serous ovarian carcinoma，C. Han et al. / Gynecologic Oncology xxx (2018) xxx–xxx，https://doi.org/10.1016/j.ygyno.2018.03.050.

作者单位：

1. Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale University School of Medicine, New Haven, CT 06520, USA
2.  Department of Biostatistics, University of Arkansas for Medical Science, Little Rock, AR 72205, USA
3. Department of Cancer Biology, Department of Oncologic Pathology, Blais Proteomic Center, Dana-Farber Cancer Institute, Boston, MA 02115, USA
4. Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA
5.Division of Cancer Imaging Research, The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
6.Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
7.Division of Gynecologic Oncology, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY 10016, USA
8.Department of Obstetrics and Gynecology, Penn Ovarian Cancer Research Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA
9.Department of Therapeutic Radiology, Yale School of Medicine, New Haven, CT 06510, USA

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