MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial

Eligibility Criteria

• * Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)
• * Clinical stage of patient is either:
• * Stage I pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse or Stage IIA/B pure seminoma
• * Stage I NSGCT OR stage I NSGCT with isolated retroperitoneal relapse or Stage IIA/B NSGCT
• * Suspected retroperitoneal disease: Lymphadenopathy in the retroperitoneum with no lymph node \>3 cm in greatest dimension with no more than 2 nodes enlarged
• * Axial imaging within 6 weeks of enrollment
• * Chest imaging (x-ray, CT or MRI) negative for metastasis within 6 weeks of enrollment
• * MiRNA-371 level drawn at any timepoint after orchiectomy
• * Retroperitoneal lymphadenopathy must be within an RPLND template
• * Biopsy of lymph node is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with GCT
• * Serum Alpha Feto Protein (AFP), β-Human Chorionic Gonadotropin (HCG), Lactate Dehydrogenase (LDH) - per the local laboratory assay \<1.5xlower normal level within 30 days of enrollment
• * Age ≥ 16 years
• * Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• * Ability to understand and the willingness to sign a written informed consent
• * Second primary malignancy
• * History of receiving chemotherapy or radiotherapy
• * Patients receiving any other investigational agent (s)
• * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements