This is a observational study aimed at evaluating miRNA 371a-3p (miRNA 371) as a specific marker for presence or absence of clinically detectable viable germ cell malignancy.
Patients must be ≥ 18 years of age.
Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/AFP). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible.
If surgery is planned, male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration.
Patients must have risk of relapse assessment determined by the local investigator prior to registration.
Patients with high risk of relapse or metastatic disease.
Patients with tumour assessments beyond the time frame required by the protocol.
Patients not complaint with the protocol schedule.
Patients with newly diagnosed testicular germ cell cancers with: 1. Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy). Patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements. 2. Moderate risk of relapse (26-50% chance of recurrence). Patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
Cohort
Prospective
Not listed
Misure of the level of miRNA37 in plasma samples
The study will prospectively collect samples and performed scans to evaluate the ability of miRNA371 in detecting (or anticipate) disease progression.
Presence/absence of malignant cells detected by miRNA371
The study will validate the capacity of miRNA371 to assess the presence of viable malignant cells otherwise not visible with standard imaging.
Relapse on Surveillance
Evidence of unequivocal clinically or pathologically confirmed recurrent germ cell tumor on surveillance
Relapse on Treatment
Evidence of unequivocal clinically or pathologically confirmed germ cell tumor during or after specific treatment for germ cell tumor including chemotherapy, radiation therapy or surgery
Relapse Free Survival
Relapse free survival is measured from the date of orchiectomy until the date of first observation of relapse on surveillance, or from the date of achieving complete remission until the date of first observation of relapse on treatment, or death due to any cause. Patients last known to be alive and without report of relapse are censored at date of last contact
Overall Survival
Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact
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