One-Step Nucleic Acid Amplification Analysis of Sentinel Lymphatic Nodes in Endometrial Cancer Patients (EU-OSNA): A European Multicenter Diagnostic Accuracy Study

IF 3.1 2区医学 Q2 ONCOLOGY

Cancer Medicine Pub Date : 2025-09-22 DOI:10.1002/cam4.71268

Jan Kostun, Krzysztof Nowosielski, Marcin A. Jedryka, David Hardisson, Stefano Restaino, Sonia Gatius, Zoltan Novak, Amaia Sagasta Lacalle, Susana Lopez, Martin Pešta, Marcin Zebalski, Piotr Lepka, María Dolores Diestro, Giuseppe Vizzielli, Xavier Matias-Guiu, Tímea Echim, Emma Natalia Camacho Urkaray, Iván Rienda, Robert Slunečko, Andrzej Czekanski, Alberto Berjón, Laura Mariuzzi, Ana Velasco, Judit Betenbuk, Isabel Guerra Merino, Pablo Padilla-Iserte, Petr Stráník, Vendula Smoligová, Jiří Presl

{"title":"One-Step Nucleic Acid Amplification Analysis of Sentinel Lymphatic Nodes in Endometrial Cancer Patients (EU-OSNA): A European Multicenter Diagnostic Accuracy Study","authors":"Jan Kostun, Krzysztof Nowosielski, Marcin A. Jedryka, David Hardisson, Stefano Restaino, Sonia Gatius, Zoltan Novak, Amaia Sagasta Lacalle, Susana Lopez, Martin Pešta, Marcin Zebalski, Piotr Lepka, María Dolores Diestro, Giuseppe Vizzielli, Xavier Matias-Guiu, Tímea Echim, Emma Natalia Camacho Urkaray, Iván Rienda, Robert Slunečko, Andrzej Czekanski, Alberto Berjón, Laura Mariuzzi, Ana Velasco, Judit Betenbuk, Isabel Guerra Merino, Pablo Padilla-Iserte, Petr Stráník, Vendula Smoligová, Jiří Presl","doi":"10.1002/cam4.71268","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>This European multicenter study aimed to assess the diagnostic accuracy of one-step nucleic acid amplification (OSNA) as the primary endpoint by comparing this method with ultrastaging for the detection of sentinel node metastases in endometrial cancer patients.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>European multicenter prospective performance study including data from 10 centers across 5 European countries. Each node, upon removal of surrounding adipose tissue, was sliced in 2 mm thick sections and equally distributed between ultrastaging and OSNA. OSNA is based on cytokeratin-19 detection, serving as a metastatic marker. Sensitivity, specificity, and concordance of OSNA versus ultrastaging were calculated at nodal and patient levels.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Seven hundred forty-three sentinel nodes from 366 patients were evaluated. Compared to ultrastaging, OSNA showed concordance, specificity, and sensitivity of 95%, 97.6%, and 41.2% at the nodal level and 93.2%, 96.2%, and 47.8% at the patient level, respectively. In reverse analysis, when compared to OSNA, the ultrastaging showed a sensitivity of 45.2% and 45.8% at the nodal and patient levels, respectively. Irrespective of the size of metastasis, both methods agreed in 14 positive and 692 negative nodes (95%). This resulted in 24 (6.56%) patients with a positive OSNA and 23 (6.28%) patients with a positive ultrastaging finding. The number of discordant nodes was 47 (6.33%), 40 (85.1%) of them were micrometastases. Benign epithelial inclusions occurred in 4 nodes (0.54%) and 4 patients (1.09%).</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Compared with ultrastaging, OSNA showed high concordance and specificity, but sensitivity was low—similar to ultrastaging compared with OSNA as an index test in reverse analysis. The main limitation in comparing the two approaches by splitting the sentinel nodes was the tissue allocation bias. As reflected in the number of discordant cases, especially at the micrometastases level. The distribution of patients with node metastases was comparable between the two methods at both the nodal and patient levels.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>German Clinical Trial Register: Nr. DRKS00021520</p>\n </section>\n </div>","PeriodicalId":139,"journal":{"name":"Cancer Medicine","volume":"14 18","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.71268","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Medicine","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cam4.71268","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Objective

This European multicenter study aimed to assess the diagnostic accuracy of one-step nucleic acid amplification (OSNA) as the primary endpoint by comparing this method with ultrastaging for the detection of sentinel node metastases in endometrial cancer patients.

Methods

European multicenter prospective performance study including data from 10 centers across 5 European countries. Each node, upon removal of surrounding adipose tissue, was sliced in 2 mm thick sections and equally distributed between ultrastaging and OSNA. OSNA is based on cytokeratin-19 detection, serving as a metastatic marker. Sensitivity, specificity, and concordance of OSNA versus ultrastaging were calculated at nodal and patient levels.

Results

Seven hundred forty-three sentinel nodes from 366 patients were evaluated. Compared to ultrastaging, OSNA showed concordance, specificity, and sensitivity of 95%, 97.6%, and 41.2% at the nodal level and 93.2%, 96.2%, and 47.8% at the patient level, respectively. In reverse analysis, when compared to OSNA, the ultrastaging showed a sensitivity of 45.2% and 45.8% at the nodal and patient levels, respectively. Irrespective of the size of metastasis, both methods agreed in 14 positive and 692 negative nodes (95%). This resulted in 24 (6.56%) patients with a positive OSNA and 23 (6.28%) patients with a positive ultrastaging finding. The number of discordant nodes was 47 (6.33%), 40 (85.1%) of them were micrometastases. Benign epithelial inclusions occurred in 4 nodes (0.54%) and 4 patients (1.09%).

Conclusion

Compared with ultrastaging, OSNA showed high concordance and specificity, but sensitivity was low—similar to ultrastaging compared with OSNA as an index test in reverse analysis. The main limitation in comparing the two approaches by splitting the sentinel nodes was the tissue allocation bias. As reflected in the number of discordant cases, especially at the micrometastases level. The distribution of patients with node metastases was comparable between the two methods at both the nodal and patient levels.

Trial Registration

German Clinical Trial Register: Nr. DRKS00021520

Abstract Image

查看原文本刊更多论文

子宫内膜癌前哨淋巴结一步核酸扩增分析（EU-OSNA）：欧洲多中心诊断准确性研究

目的本欧洲多中心研究旨在评估一步核酸扩增（one-step nucleic acid amplification， OSNA）作为诊断子宫内膜癌前哨淋巴结转移的主要终点，并将其与超声检测进行比较。方法欧洲多中心前瞻性绩效研究，包括来自欧洲5个国家10个中心的数据。在去除周围脂肪组织后，将每个淋巴结切成2mm厚的切片，并在超声和OSNA之间均匀分布。OSNA是基于细胞角蛋白19检测，作为转移标志物。在淋巴结和患者水平上计算OSNA与超调的敏感性、特异性和一致性。结果366例患者共743个前哨淋巴结被检查。与超声相比，OSNA在淋巴结水平上的一致性、特异性和敏感性分别为95%、97.6%和41.2%，在患者水平上的一致性、特异性和敏感性分别为93.2%、96.2%和47.8%。在反向分析中，与OSNA相比，超调在淋巴结和患者水平上的敏感性分别为45.2%和45.8%。不论转移灶大小，两种方法在14例阳性和692例阴性淋巴结（95%）中一致。结果显示，24例（6.56%）患者为OSNA阳性，23例（6.28%）患者为超声心动图阳性。不一致淋巴结47例（6.33%），其中微转移40例（85.1%）。良性上皮包涵体4例（0.54%），患者4例（1.09%）。结论在反向分析中，OSNA作为指标试验与超期相比具有较高的一致性和特异性，但敏感性较低，与超期相比类似。通过分离前哨淋巴结比较两种方法的主要限制是组织分配偏差。这反映在不一致病例的数量上，特别是在微转移水平上。两种方法在淋巴结和患者水平上的淋巴结转移患者分布具有可比性。德国临床试验注册：编号：DRKS00021520

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.