A Study of miRNA 371 in Patients With Germ Cell Tumors

Study Overview
=================
Brief Summary
-----------------
This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. 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: I. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data. II. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531. OUTLINE: Patients undergo collection of blood every 3-6 months for up to 3 years.

Official Title
-----------------
A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors

Conditions
-----------------
Germ Cell Tumor, Metachronous Malignant Neoplasm, Seminoma, Stage I Testicular Cancer AJCC v8, Stage IA Testicular Cancer AJCC v8, Stage IB Testicular Cancer AJCC v8, Stage IS Testicular Cancer AJCC v8

Intervention / Treatment
-----------------
* Other: Biomarker Analysis
* Procedure: Blood Product Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (blood collection)<br>Patients undergo collection of blood every 3-6 months for up to 3 years. | Other: Biomarker Analysis<br>* Correlative study<br>Procedure: Blood Product Collection<br>* Undergo collection of blood<br>* Other names: Collection, Blood Products;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate positive predictive value of miRNA 371 in early stage testicular seminoma and nonseminoma patients | Positive predictive value will be estimated using plasma miRNA 371 expression at relapse. | Up to 3 years | 
| To bank blood specimens of patients at low risk and moderate risk of relapse | 10 ml whole blood will be collected at time points specified by the protocol. | Up to 3 years |