Implementation of microRNA-371 into the follow-up protocol of men with localised testicular germ cell tumors (microRNA-TARGET)

About the study

About 60% of patients with testicular germ cell tumours (GCTs) present with localised, non-metastatic disease. After orchiectomy, most men are included in surveillance programmes, through which regular measurements of the serum tumour markers alpha-fetoprotein (AFP) and human chorionic gonadotropin (HCG) are collected. These serum markers only detect about 60% of non-seminoma and less than 5% of seminoma recurrences; therefore, additional cross- sectional imaging (computerized tomography [CT] or magnetic resonance imaging [MRI]) is required during active surveillance. However, the use of CT can result in considerable cumulative radiation exposure in this young patient population, and both CT and MRI add relevant healthcare costs. Serum microRNA-371 has emerged as a blood- based biomarker that can reliably predict macroscopic GCTs; however, pure teratoma cannot be detected using microRNA-371

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Previous results of our group indicate that recurrences can be detected earlier by serum microRNA-371 measurements than standard follow-up schedules. Based on this, we plan the translation from bench to bedside through the implementation of microRNA- 371 into follow-up schedules. This next step is now feasible because routine microRNA-371 measurements can now be taken using a CE-certified qRT-PCR kit from the company miRdetect (Bremerhaven, Germany). 

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The aim of the study is to:

 - Show the feasibility of measuring microRNA-371 levels in the daily clinical routine using a CE-certified test

 - Confirm the high diagnostic accuracy of the CE-certified microRNA-371 test in the follow-up setting compared to the accuracy of the standard follow-up investigations, including cross-sectional imaging and AFP and HCG measurements

 - Determine the level of microRNA-371 at which macroscopic disease can be detected