MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
Purpose
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
Condition
- Malignant Testicular Germ Cell Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts 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) 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 8 weeks of enrollment if stage II patient - miRNA-371 can be drawn and sent for analysis at time of consent - Enrollment within 1 year after orchiectomy for stage I patients - Enrollment 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) <50 ng/ml, β-Human Chorionic Gonadotropin (β-HCG) 25 mIU/ml within 42 days (6 weeks) of enrollment - Age ≥ 18 years - Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
- Second primary malignancy - 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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort 1 | This cohort involves all CS-I GCT patients which is defined as GCT in orchiectomy specimen (seminoma and NSGCT), normal conventional staging imaging, and normal/low stable tumor markers. The current standard of care for management of CS-I disease is either surveillance, RPLND, or systemic therapy. Surveillance is preferred however is largely dependent on clinician discretion. In this cohort miRNA-371 level will be drawn at any timepoint after orchiectomy. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years. |
|
| Cohort 2 | This cohort involves all GCT patients with radiographically enlarged retroperitoneal lymph nodes <3 cm (initial CS-I GCT patients with radiographic evidence of retroperitoneal lymph node enlargement and de-novo CS-II patients). In this cohort, miRNA-371 level will be drawn at any timepoint after orchiectomy. Patients with initial CS-I and retroprertioneal relapse/ de-novo CS-II disease and normal miRNA-371 levels will undergo reassessment (repeat cross sectional imaging and miRNA level) after 6 weeks. If mass is stable and miRNA-371 level remains normal then patients will continue on surveillance. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years. |
|
Recruiting Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- University of Southern California
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.