Antioch, California 94531

  • Stage IS Testicular Cancer AJCC v8

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

S1823


NCT ID:

NCT04435756


Secondary ID:

NCI-2019-06177


Study Acronym:


Brief Title:

A Study of miRNA 371 in Patients With Germ Cell Tumors


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

956


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Craig R Nichols
Principal Investigator
Southwest Oncology Group
Primary Contact:Patricia O'Kane
210-614-8808
pokane@swog.org
Backup Contact:Dana Sparks, MAT
210-614-8808 ext. 1004
210-614-8808
dsparks@swog.org

Study Dates

Start Date:June 1, 2020
Completion Date:October 1, 2025
Completion Type:Anticipated
Primary Completion Date:June 1, 2025
Primary Completion Type:Anticipated
Verification Date:September 2022
Last Changed Date:September 13, 2022
First Received Date:June 15, 2020

Study Outcomes

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

Study Interventions

Intervention Type:Other
Name:Biomarker Analysis
Description:Correlative study
Arm Name:Observational (blood collection)
Intervention Type:Procedure
Name:Blood Product Collection
Description:Undergo collection of blood
Arm Name:Observational (blood collection)
Other Name:Collection, Blood Products

Study Arms

Study Arm Type:Other
Arm Name:Observational (blood collection)
Description:Patients undergo collection of blood every 3-6 months for up to 3 years.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Blood
Study Population: Patients with newly diagnosed germ cell tumor
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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