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Article

MicroRNA-371a-3p Represents a Novel and Effective Diagnostic Marker for Testicular Germ Cell Tumours: A Real-World Prospective Comparison with Conventional Approaches

1
Department of Urology, Eberhard-Karls-University of Tübingen, 72076 Tübingen, Germany
2
Department of Urology, Central Hospital of Bolzano, 39100 Bolzano, Italy
3
Department of Pathology, Central Hospital of Bolzano, 39100 Bolzano, Italy
4
Medical School, Sigmund Freud Private University, 1020 Vienna, Austria
5
Department of Urology, Medical University of Innsbruck, 6020 Innsbruck, Austria
*
Authors to whom correspondence should be addressed.
Pathophysiology 2025, 32(4), 54; https://doi.org/10.3390/pathophysiology32040054
Submission received: 18 August 2025 / Revised: 18 September 2025 / Accepted: 1 October 2025 / Published: 6 October 2025

Abstract

Background/Objectives: Testicular germ cell tumours (GCT) have high cure rates, especially in early stages. MicroRNA-371a-3p (M371) has recently emerged as a highly sensitive biomarker for malignant GCTs, except teratoma. This study aimed to evaluate the diagnostic performance of M371-test in a real-life clinical setting, compared to conventional markers alpha-fetoprotein (AFP), lactate-dehydrogenase (LDH), and beta-human chorionic gonadotropin (β-HCG) in patients with suspected GCT. Methods: The study, approved by the Ethic-Committee of the Provincial Hospital of Bolzano (N.97-2021), included 91 M371-tests, performed from March 2021 to May 2025. A total of 75 patients had suspected GCT; 19 healthy males served as control. Serum levels of M371, AFP, LDH, and β-HCG were compared with final histopathological diagnosis. M371 was also assessed in controls to evaluate test performance. Secondary analyses investigated correlations between preoperative M371 levels and tumour size in non-metastatic patients, and between M371-levels and clinical stage in the entire GCT cohort. A cut-off of RQ > 5 (relative quantification) was used to calculate sensitivity, specificity, and predictive values. Results: M371 showed a sensitivity of 90.9% and specificity of 89.3%, outperforming in terms of sensitivity AFP (20.4%/96.4%), LDH (40.9%/96.4%), and β-HCG (43.1%/100%). Positive predictive value (PPV) and negative predictive value (NPV) were 93.0% and 86.2%, respectively. Sensitivity was 95% for non-seminomas and 87.5% for seminomas. In non-metastatic patients, M371 levels correlated with tumour size and were significantly higher in advanced stages (median RQ 1128.35 vs. 98.36; p = 0.015). Conclusions: M371 showed excellent diagnostic performance, even for small tumours, supporting its clinical use. Further studies are needed to define its role in treatment planning and follow-up.
Keywords: testicular germ-cell tumour; MiRNA; tumour markers; small testicular masses; seminoma; non-seminoma; real-life study testicular germ-cell tumour; MiRNA; tumour markers; small testicular masses; seminoma; non-seminoma; real-life study

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MDPI and ACS Style

Palermo, M.; D’Elia, C.; Mazzucato, G.; Mian, C.; Schwienbacher, C.; Hanspeter, E.; Clauser, S.; Palermo, S.M.; Pycha, A.; Heidegger, I.; et al. MicroRNA-371a-3p Represents a Novel and Effective Diagnostic Marker for Testicular Germ Cell Tumours: A Real-World Prospective Comparison with Conventional Approaches. Pathophysiology 2025, 32, 54. https://doi.org/10.3390/pathophysiology32040054

AMA Style

Palermo M, D’Elia C, Mazzucato G, Mian C, Schwienbacher C, Hanspeter E, Clauser S, Palermo SM, Pycha A, Heidegger I, et al. MicroRNA-371a-3p Represents a Novel and Effective Diagnostic Marker for Testicular Germ Cell Tumours: A Real-World Prospective Comparison with Conventional Approaches. Pathophysiology. 2025; 32(4):54. https://doi.org/10.3390/pathophysiology32040054

Chicago/Turabian Style

Palermo, Margherita, Carolina D’Elia, Giovanni Mazzucato, Christine Mian, Christine Schwienbacher, Esther Hanspeter, Silvia Clauser, Salvatore Mario Palermo, Armin Pycha, Isabel Heidegger, and et al. 2025. "MicroRNA-371a-3p Represents a Novel and Effective Diagnostic Marker for Testicular Germ Cell Tumours: A Real-World Prospective Comparison with Conventional Approaches" Pathophysiology 32, no. 4: 54. https://doi.org/10.3390/pathophysiology32040054

APA Style

Palermo, M., D’Elia, C., Mazzucato, G., Mian, C., Schwienbacher, C., Hanspeter, E., Clauser, S., Palermo, S. M., Pycha, A., Heidegger, I., Tsaur, I., & Trenti, E. (2025). MicroRNA-371a-3p Represents a Novel and Effective Diagnostic Marker for Testicular Germ Cell Tumours: A Real-World Prospective Comparison with Conventional Approaches. Pathophysiology, 32(4), 54. https://doi.org/10.3390/pathophysiology32040054

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