MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
- Conditions
- Malignant Testicular Germ Cell Tumor
- Interventions
- Other: Non-Interventional Study
- Registration Number
- NCT06060873
- Lead Sponsor
- University of Southern California
- Brief Summary
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 418
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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
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Chest imaging (x-ray, CT or MRI) negative for metastasis within 6 weeks of enrollment
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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
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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
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Ability to understand and the willingness to sign a written informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational Non-Interventional 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.
- Primary Outcome Measures
Name Time Method Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy Through study completion, up to 5 years The positive predictive value of pre-operatively elevated miRNA-371 levels in predicting active GCT will be determined by pathologic review of RPLND specimens.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
USC / Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Los Angeles County-USC Medical Center
🇺🇸Los Angeles, California, United States