MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial

Study Overview
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Brief Summary
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This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.

Detailed Description
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PRIMARY OBJECTIVE: I. To measure the accuracy of the blood-based biomarker miRNA-371 to predict pre-operatively the presence of active germ cell malignancy. OUTLINE: This is an observational study. Patients undergo blood sample collection during screening and throughout the study. Patients whose screening blood samples show elevated miRNA-371 proceed to standard RPLND surgery. Patients whose screening blood samples show normal levels of miRNA-371 undergo standard surveillance followed by standard RPLND surgery at the time of elevated miRNA-371 levels. Patients may also have their medical records reviewed.

Official Title
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Phase II Trial of Serum Micro RNA-371 in Detecting Active Germ Cell Tumors in Patients With Suspected Regional Disease - (MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial)

Conditions
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Malignant Testicular Germ Cell Tumor

Intervention / Treatment
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* Other: Non-Interventional Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT) Clinical stage of patient is either: Stage I pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse or Stage IIA/B pure seminoma Stage I NSGCT OR stage I NSGCT with isolated retroperitoneal relapse or Stage IIA/B NSGCT Suspected retroperitoneal disease: Lymphadenopathy in the retroperitoneum with no lymph node >3 cm in greatest dimension with no more than 2 nodes enlarged Axial imaging within 6 weeks of enrollment Chest imaging (x-ray, CT or MRI) negative for metastasis within 6 weeks of enrollment MiRNA-371 level drawn at any timepoint after orchiectomy Retroperitoneal lymphadenopathy must be within an RPLND template Biopsy of lymph node is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with GCT Serum Alpha Feto Protein (AFP), β-Human Chorionic Gonadotropin (HCG), Lactate Dehydrogenase (LDH) - per the local laboratory assay <1.5xlower normal level within 30 days of enrollment Age ≥ 16 years Eastern Cooperative Oncology Group (ECOG) performance status ≤2 Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Second primary malignancy History of receiving chemotherapy or radiotherapy Patients receiving any other investigational agent (s) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients undergo blood sample collection during screening and throughout the study. Patients whose screening blood samples show elevated miRNA-371 proceed to standard RPLND surgery. Patients whose screening blood samples show normal levels of miRNA-371 undergo standard surveillance followed by standard RPLND surgery at the time of elevated miRNA-371 levels. Patients may also have their medical records reviewed. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy | The positive predictive value of pre-operatively elevated miRNA-371 levels in predicting active GCT will be determined by pathologic review of RPLND specimens. | Through study completion, up to 5 years |