Clinical evaluation of the role of miRNA 371 in small testicular masses. Results of the “S1STeM 371” Trial

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2025-05-16 DOI:10.1016/j.ejca.2025.115494

Sebastiano Nazzani , Adele Busico , Valentina Bernasconi , Martina Bruniera , Martina Gianninò , Daniele Rusconi , Jessica Gualtieri , Carlo Silvani , Alberto Macchi , Tullio Torelli , Silvia Stagni , Antonio Tesone , Cesare Saitta , Iolanda Capone , Tommaso Cascella , Rodolfo Lanocita , Marco Barella , Biagio Paolini , Federica Perrone , Giancarlo Albo , Nicola Nicolai

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引用次数: 0

Abstract

Aim of the study

Incidental small testicular masses (STMs) pose the dilemma of invasive Vs surveillance. To test miRNA 371 kit (M371, CE approved) in predicting germ cells tumor (GCT) in patients with STM.

Methods

Thirty-two consecutive men with a STM between 5 and 20 mm have been prospectively accrued. All patients had miRNA 371 blood testing before surgery. Serum miRNA processation was standardized and certified and following transcription into cDNA with an endogeneous control. The Relative Quantity (RQ) was determined by quantitative polymerase chain reaction (qPCR) following preamplification. Different RQ cut-offs were tested. The results of pre-surgery 371 miRNA were compared to definitive pathology.

Results

Median lesion size was 14 mm (IQR 8–18 mm). 21 of 32 patients (65.6 %) had GCTs: 14 seminomatous (S)GCTs, 6 non-seminomatous (NS)GCTs, 1 in-situ germ cell neoplasia (GCNIS). Median RQ was 57.50 (IQR 18.50, 223.75) among GCT patients and 5.00 (IQR 1.00, 13.50) in patients without GCTs. We tested for sensitivity (SE), specificity (SP), positive (PPV) and negative predictive value (NPV) at different RQ cut-offs of 5 and 10. SE, SP, PPV and NPV were 100 %, 45 %, 78.1 %, 100 % 95.2 %, 63.7 %, 83.6 %, 87.3 %, respectively.

Conclusions

Serum miRNA 371 can predict GCTs in selected patients with 5–20 mm STM. These results need to be refined by standardizing the analytical process.

查看原文本刊更多论文

miRNA 371在小睾丸肿块中作用的临床评价“S1STeM 371”试验结果

目的：偶发性睾丸小肿块（STMs）给有创性Vs监测带来了困境。目的：探讨miRNA 371试剂盒（M371， CE批准）对STM患者生殖细胞肿瘤（GCT）的预测作用。方法前瞻性累积32例STM在5 ~ 20 mm之间的男性。所有患者术前均进行miRNA 371血液检测。血清miRNA加工标准化并经过认证，然后用内源性对照转录成cDNA。预扩增后采用定量聚合酶链反应（qPCR）测定相对量（RQ）。测试了不同的RQ截止值。将术前371个miRNA结果与最终病理结果进行比较。结果中位病灶大小为14 mm （IQR 8 ~ 18 mm）。32例患者中有21例（65.6% %）发生gct: 14例为半细胞性(S) gct， 6例为非半细胞性（NS） gct， 1例为原位生殖细胞瘤（GCNIS）。GCT患者的中位RQ为57.50 (IQR为18.50,223.75)，未GCT患者的中位RQ为5.00 （IQR为1.00,13.50）。我们在不同的RQ截止值为5和10时测试了敏感性（SE）、特异性（SP）、阳性（PPV）和阴性预测值（NPV）。SE、SP PPV和NPV 100 %,45 %,78.1 %,100  % % 95.2,63.7 % 83.6 %,分别87.3 %。结论血清miRNA 371可预测5 ~ 20 mm STM患者的gct。这些结果需要通过标准化的分析过程来改进。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.