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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.
This is a observational cohort study to evaluate miRNA 371 in male patients with history of germ cell tumor or newly diagnosed germ cell tumor.
Patients with newly diagnosed testicular germ cell cancers will be stratified in:
The BRIDGE study evaluate the plasma expression of miRNA 371 as biomarker of relapse and its ability to detect germ cell malignancy within each of the early stage testicular seminoma and nonseminoma groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low risk of relapse | 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. | ||
| Moderate risk of relapse | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 months |
| 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. | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse on Surveillance | Evidence of unequivocal clinically or pathologically confirmed recurrent germ cell tumor on surveillance | 48 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed testicular germ cell cancers with:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pasquale Rescigno, MD | Contact | +390119933601 | pasquale.rescigno@ircc.it | |
| Ilaria Buondonno, PhD | Contact | +390119933393 | ilaria.buondonno@ircc.it |
| Name | Affiliation | Role |
|---|---|---|
| Pasquale Rescigno, MD | Fondazione del Piemonte per l'Oncologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia | Recruiting | Candiolo | Turin | 10060 | Italy |
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| ID | Term |
|---|---|
| C563236 | Testicular Germ Cell Tumor |
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10 ml of blood will be collected at the time points listed below in Streck cell-free DNA collection tube. Schedule is based on the patient's risk of relapse category. Specimens for miRNA 371 analysis will be collected at the time of standard of care clinical blood draws in order to minimize blood draws in the subject.
Submission Schedule for Low Risk of Relapse Patients:
Submission Schedule for Moderate-Risk Patients:
| 48 months |
| 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 | 48 months |
| 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 | 48 months |