Testicular Germ Cell Tumor
Conditions
Brief summary
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.
Detailed description
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: 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. 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.
Interventions
None listed
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected. * Patients must have beta-human chorionic gonadotropin (beta-HCG), alpha- fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments within 42 days prior to registration. * Patients must agree to provide informed consent and required blood specimens for the duration of the study.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Misure of the level of miRNA37 in plasma samples | 48 months | 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 | 48 months | The study will validate the capacity of miRNA371 to assess the presence of viable malignant cells otherwise not visible with standard imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse on Surveillance | 48 months | Evidence of unequivocal clinically or pathologically confirmed recurrent germ cell tumor on surveillance |
| Relapse on Treatment | 48 months | 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 | 48 months | 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 | 48 months | 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 |
Countries
Italy
Contacts
CONTACTPasquale Rescigno, MD
CONTACTIlaria Buondonno, PhD
PRINCIPAL_INVESTIGATORPasquale Rescigno, MD
Fondazione del Piemonte per l'Oncologia
Outcome results
None listed