A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors.
Primary Objective:
To estimate the positive predictive value within each of the early stage testicular seminoma and nonseminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy.
Secondary Objectives:
1. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data.
2. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Childrens Oncology Group study AGCT 1531.
- Rutgers Cancer Institute of New Jersey
Inclusion Criteria
- Patients must have a new diagnosis of a germ cell tumor. confirmed pathologically or
serologically (diagnostic elevation of human chorionic gonadotropin
[HCG]/alpha-fetoprotein [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 be registered within 42 days after diagnosis and prior to initiation of
a management plan or treatment for the disease
- 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
- NOTE: If the patient had an orchiectomy prior to registration, report tumor
marker values before and after surgery on the Baseline Tumor Marker form
- Patients must have risk of relapse assessment determined by the local investigator
prior to registration
- Patients must agree to submit required specimens for defined translational medicine
studies. These specimens are drawn at the same time as standard laboratory evaluations
(beta-HCG, AFP, and LDH); NOTE: Ideally, patients should be willing to return to their
center performing surveillance (registering site) for the duration of the study to
ensure that specimens are timed to standard clinical observations (the registering
site's surveillance schedule)
- Patients must be offered participation in specimen banking for future research. With
patient's consent, specimens must be submitted.
- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.