Phase II Trial of Serum Micro RNA-371 in Detecting Active Germ Cell Tumors in Patients with Suspected Regional Disease.

Inclusion 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 abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 3 months of enrollment if stage I patient - Axial abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 6 weeks of enrollment if stage II patient - MiRNA-371 level drawn within 1 year after orchiectomy for stage I patients - MiRNA-371 level drawn at any timepoint after orchiectomy for stage II patients - 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 42 days (6 weeks) of enrollment - Age ≥ 16 years - Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: - 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