A Study of MiRNA 371 in Patients with Germ Cell Tumors

SWOG Cancer Research Network

Status

Active, not recruiting

Conditions

Germ Cell Tumor

Metachronous Malignant Neoplasm

Stage IB Testicular Cancer AJCC V8

Stage I Testicular Cancer AJCC V8

Stage IA Testicular Cancer AJCC V8

Stage is Testicular Cancer AJCC V8

Seminoma

Treatments

Other: Biomarker Analysis

Procedure: Blood Product Collection

Study type

Observational

Funder types

NETWORK

NIH

Identifiers

NCT04435756

NCI-2019-06177 (Registry Identifier)

UG1CA189974 (U.S. NIH Grant/Contract)

S1823 (Other Identifier)

SWOG-S1823 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

956 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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