MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical Stage I Disease, Clinical Stage I with relapse, CSII Disease.
- Who it may be relevant to
- Registry conditions: Malignant Testicular Germ Cell Tumor. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Interventions
- Other Clinical 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. - Other Clinical 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.
Primary outcome measures
- Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy [Time frame: Through study completion, up to 5 years]
Secondary outcome measures (3)
- The 2-year disease-free survival [Time frame: Through study completion, up to 5 years]
- Persistence of positive postoperative miRNA as a predictor of relapse at follow-up [Time frame: Through study completion, up to 5 years]
- Negative predictive value of negative pre-operative miRNA [Time frame: Through study completion, up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 5 centers
- University of Alabama at Birmingham Cancer Center — Birmingham
- Loma Linda University Medical Center — Loma Linda
- Los Angeles County-USC Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
- Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center — New Brunswick
Identifiers
NCT: NCT06060873 · 4T-22-2 · NCI-2023-00412 · 4T-22-2 · P30CA014089