MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
Study Details
Study Description
Brief Summary
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
PRIMARY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Observational 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
Non-interventional study
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)
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Clinical stage of patient is either:
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Stage I pure seminoma OR stage I pure seminoma with isolated retroperitoneal relapse or Stage IIA/B pure seminoma
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Stage I NSGCT OR stage I NSGCT with isolated retroperitoneal relapse or Stage IIA/B NSGCT
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Suspected retroperitoneal disease: Lymphadenopathy in the retroperitoneum with no lymph node >3 cm in greatest dimension with no more than 2 nodes enlarged
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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
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Retroperitoneal lymphadenopathy must be within an RPLND template
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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
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Age ≥ 16 years
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Eastern Cooperative Oncology Group (ECOG) performance status ≤2
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Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
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Second primary malignancy
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History of receiving chemotherapy or radiotherapy
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Patients receiving any other investigational agent (s)
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Los Angeles County-USC Medical Center | Los Angeles | California | United States | 90033 |
2 | USC / Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
Sponsors and Collaborators
- University of Southern California
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Siamak Daneshmand, MD, University of Southern California
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4T-22-2
- NCI-2023-00412
- 4T-22-2
- P30CA014089