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)
University of Southern California
Summary
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
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 re…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 * For subjects with retroperitoneal lymphadenopathy: 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) with…
Interventions
- OtherClinical Stage I Disease
Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or standard surveillance. Surveillance will follow until year 5.
- OtherClinical Stage I with relapse, CSII Disease
Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or reassessment and then surveillance will follow until year 5.
Locations (5)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Loma Linda University Medical CenterLoma Linda, California
- Los Angeles County-USC Medical CenterLos Angeles, California
- USC / Norris Comprehensive Cancer CenterLos Angeles, California
- Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer CenterNew Brunswick, New Jersey