Dieckmann, Klaus-Peter, Radtke, Arlo, Geczi, Lajos, Matthies, Cord, Anheuser, Petra, Eckardt, Ulrike, Sommer, Joerg, Zengerling, Friedemann, Trenti, Emanuela, Pichler, Renate, Belz, Hanjo, Zastrow, Stefan, Winter, Alexander, Melchior, Sebastian, Hammel, Johannes, Kranz, Jennifer, Bolten, Marius, Krege, Susanne, Haben, Bjoern, Loidl, Wolfgang, Ruf, Christian Guido, Heinzelbecker, Julia, Heidenreich, Axel, Cremers, Jann Frederik, Oing, Christoph, Hermanns, Thomas, Fankhauser, Christian Daniel, Gillessen, Silke ORCID: 0000-0001-5746-6555, Reichegger, Hermann, Cathomas, Richard, Pichler, Martin, Hentrich, Marcus, Eredics, Klaus, Lorch, Anja, Wuelfing, Christian, Peine, Sven, Wosniok, Werner, Bokemeyer, Carsten and Belge, Gazanfer (2019). Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study. J. Clin. Oncol., 37 (16). S. 1412 - 1429. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

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 beta-human chorionic gonadotropin, alpha-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%. alpha-Fetoprotein, beta-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. (C) 2019 by American Society of Clinical Oncology

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Dieckmann, Klaus-PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Radtke, ArloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Geczi, LajosUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Matthies, CordUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Anheuser, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eckardt, UlrikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sommer, JoergUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zengerling, FriedemannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Trenti, EmanuelaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pichler, RenateUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Belz, HanjoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zastrow, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Winter, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Melchior, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hammel, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kranz, JenniferUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bolten, MariusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krege, SusanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haben, BjoernUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Loidl, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruf, Christian GuidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinzelbecker, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heidenreich, AxelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cremers, Jann FrederikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oing, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hermanns, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fankhauser, Christian DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gillessen, SilkeUNSPECIFIEDorcid.org/0000-0001-5746-6555UNSPECIFIED
Reichegger, HermannUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cathomas, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pichler, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hentrich, MarcusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eredics, KlausUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lorch, AnjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wuelfing, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peine, SvenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wosniok, WernerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bokemeyer, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Belge, GazanferUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-146350
DOI: 10.1200/JCO.18.01480
Journal or Publication Title: J. Clin. Oncol.
Volume: 37
Number: 16
Page Range: S. 1412 - 1429
Date: 2019
Publisher: AMER SOC CLINICAL ONCOLOGY
Place of Publication: ALEXANDRIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
LYMPH-NODE DISSECTION; MICRORNAS MIR-371-3; PRACTICE GUIDELINES; FOLLOW-UP; CANCER; MARKERS; DIAGNOSIS; MANAGEMENTMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/14635

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