Status:
SUSPENDED
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Testicular Germ Cell Tumor
Eligibility:
MALE
16+ years
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. ...
Eligibility Criteria
Inclusion
- 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 abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 3 months of enrollment if stage I patient
- Axial abdominal/pelvic imaging (CT or MRI) and chest imaging (x-ray, CT or MRI) within 6 weeks of enrollment if stage II patient
- MiRNA-371 level drawn within 1 year after orchiectomy for stage I patients
- MiRNA-371 level drawn at any timepoint after orchiectomy for stage II patients
- 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 42 days (6 weeks) of enrollment
- Age ≥ 16 years
- Ability to understand and the willingness to sign a written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
June 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 8 2028
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT06060873
Start Date
June 8 2023
End Date
December 8 2028
Last Update
October 9 2025
Active Locations (2)
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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