Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study
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Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study. / Dieckmann, Klaus-Peter; Radtke, Arlo; Geczi, Lajos; Matthies, Cord; Anheuser, Petra; Eckardt, Ulrike; Sommer, Jörg; Zengerling, Friedemann; Trenti, Emanuela; Pichler, Renate; Belz, Hanjo; Zastrow, Stefan; Winter, Alexander; Melchior, Sebastian; Hammel, Johannes; Kranz, Jennifer; Bolten, Marius; Krege, Susanne; Haben, Björn; Loidl, Wolfgang; Ruf, Christian Guido; Heinzelbecker, Julia; Heidenreich, Axel; Cremers, Jann Frederik; Oing, Christoph; Hermanns, Thomas; Fankhauser, Christian Daniel; Gillessen, Silke; Reichegger, Hermann; Cathomas, Richard; Pichler, Martin; Hentrich, Marcus; Eredics, Klaus; Lorch, Anja; Wülfing, Christian; Peine, Sven; Wosniok, Werner; Bokemeyer, Carsten; Belge, Gazanfer.
In: J CLIN ONCOL, Vol. 37, No. 16, 01.06.2019, p. 1412-1423.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study
AU - Dieckmann, Klaus-Peter
AU - Radtke, Arlo
AU - Geczi, Lajos
AU - Matthies, Cord
AU - Anheuser, Petra
AU - Eckardt, Ulrike
AU - Sommer, Jörg
AU - Zengerling, Friedemann
AU - Trenti, Emanuela
AU - Pichler, Renate
AU - Belz, Hanjo
AU - Zastrow, Stefan
AU - Winter, Alexander
AU - Melchior, Sebastian
AU - Hammel, Johannes
AU - Kranz, Jennifer
AU - Bolten, Marius
AU - Krege, Susanne
AU - Haben, Björn
AU - Loidl, Wolfgang
AU - Ruf, Christian Guido
AU - Heinzelbecker, Julia
AU - Heidenreich, Axel
AU - Cremers, Jann Frederik
AU - Oing, Christoph
AU - Hermanns, Thomas
AU - Fankhauser, Christian Daniel
AU - Gillessen, Silke
AU - Reichegger, Hermann
AU - Cathomas, Richard
AU - Pichler, Martin
AU - Hentrich, Marcus
AU - Eredics, Klaus
AU - Lorch, Anja
AU - Wülfing, Christian
AU - Peine, Sven
AU - Wosniok, Werner
AU - Bokemeyer, Carsten
AU - Belge, Gazanfer
PY - 2019/6/1
Y1 - 2019/6/1
N2 - 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.
AB - 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.
U2 - 10.1200/JCO.18.01480
DO - 10.1200/JCO.18.01480
M3 - SCORING: Journal article
C2 - 30875280
VL - 37
SP - 1412
EP - 1423
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 16
ER -