Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study.

Autor:	Dieckmann KP; Asklepios Klinik Altona, Hamburg, Germany.; 2 Albertinen-Krankenhaus Hamburg, Hamburg, Germany., Radtke A; 3 University of Bremen, Bremen, Germany., Geczi L; 4 National Institute of Oncology, Budapest, Hungary., Matthies C; 5 Bundeswehrkrankenhaus Hamburg, Hamburg, Germany., Anheuser P; 2 Albertinen-Krankenhaus Hamburg, Hamburg, Germany., Eckardt U; 6 St Elisabeth Krankenhaus, Leipzig, Germany., Sommer J; 7 St Franziskus Hospital, Lohne, Germany., Zengerling F; 8 University of Ulm, Ulm, Germany., Trenti E; 9 Krankenhaus Bozen, Bolzano, Italy., Pichler R; 10 Medical University Innsbruck, Innsbruck, Austria., Belz H; 11 Zeisigwaldkliniken, Chemnitz, Germany., Zastrow S; 12 Universitätsklinikum Carl Gustav Carus, Dresden, Germany., Winter A; 13 Carl von Ossietzky University, Oldenburg, Germany., Melchior S; 14 Klinikum Bremen-Mitte, Bremen, Germany., Hammel J; 14 Klinikum Bremen-Mitte, Bremen, Germany., Kranz J; 15 St Antonius Hospital, Eschweiler, Germany., Bolten M; 16 Ameos Klinikum, Geestland, Germany., Krege S; 17 Klinikum Essen-Mitte Huyssenstiftung, Essen, Germany., Haben B; 18 St Marienkrankenhaus, Ahaus, Germany., Loidl W; 19 Ordensklinikum Barmherzige Schwestern, Linz, Austria., Ruf CG; 20 Bundeswehrzentralkrankenhaus, Koblenz, Germany., Heinzelbecker J; 21 Universitätsklinikum Saarland, Homburg, Germany., Heidenreich A; 22 Universitätsklinikum Cologne, Cologne, Germany., Cremers JF; 23 Universitätsklinikum Münster, Münster, Germany., Oing C; 24 Universitätsklinikum Eppendorf, Hamburg, Germany., Hermanns T; 25 Universitätsspital Zürich, Zurich, Switzerland., Fankhauser CD; 25 Universitätsspital Zürich, Zurich, Switzerland., Gillessen S; 26 Kantonsspital, St Gallen, Switzerland., Reichegger H; 26 Kantonsspital, St Gallen, Switzerland., Cathomas R; 27 Kantonsspital Graubünden, Chur, Switzerland., Pichler M; 28 Medical University Graz, Graz, Austria., Hentrich M; 29 Rotkreuzklinikum, Munich, Germany., Eredics K; 30 Kaiser Franz Josef Spital, Wien, Austria., Lorch A; 31 Urologische Universitätsklinik der Heinrich Heine Universität, Düsseldorf, Germany., Wülfing C; Asklepios Klinik Altona, Hamburg, Germany., Peine S; 24 Universitätsklinikum Eppendorf, Hamburg, Germany., Wosniok W; 3 University of Bremen, Bremen, Germany., Bokemeyer C; 24 Universitätsklinikum Eppendorf, Hamburg, Germany., Belge G; 3 University of Bremen, Bremen, Germany.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2019 Jun 01; Vol. 37 (16), pp. 1412-1423. Date of Electronic Publication: 2019 Mar 15.
DOI:	10.1200/JCO.18.01480
Abstrakt:	Purpose: Previous studies suggested that serum levels of microRNA (miR)-371a-3p (so-called M371 test) have a much higher sensitivity and specificity than the classic markers of testicular germ cell tumors (GCTs) and are applicable toward both seminoma and nonseminoma. We sought to confirm the usefulness of this test as a novel biomarker for GCT. Patients and Methods: In a prospective, multicentric study, serum samples of 616 patients with testicular GCTs and 258 male controls were examined for serum levels of miRNA-371a-3p (miR levels) by quantitative polymerase chain reaction. The GCT population encompassed 359 patients with seminoma and 257 with nonseminoma; 371 had clinical stage I disease, 201 had systemic disease, and 46 had relapses. Paired measurements before and after orchiectomy were performed in 424 patients; 118 with systemic disease had serial measurements during treatment. miR levels were compared with those of β-human chorionic gonadotropin, α-fetoprotein, and lactate dehydrogenase. Results: For the primary diagnosis of GCT, the M371 test showed a sensitivity of 90.1%, a specificity of 94.0%, an area under the curve of 0.966 upon receiver operating characteristic analysis, and a positive predictive value of 97.2%. α-Fetoprotein, β-human chorionic gonadotropin, and lactate dehydrogenase had sensitivities of less than 50% in seminoma and slightly higher sensitivities in nonseminomas. miR levels were significantly associated with clinical stage, primary tumor size, and response to treatment. Relapses had elevated miR levels that subsequently dropped to normal upon remission. Teratoma did not express miR-371a-3p. Conclusion: The M371 test outperforms the classic markers of GCT with both a sensitivity and a specificity greater than 90%. All histologic subgroups, except teratoma, express this marker. The test could be considered for clinical implementation after further validation.
Databáze:	MEDLINE
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