Clinical trial · Observational
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
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)
NCT06060873CI-TRIAL-00123102recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Testicular Germ Cell Tumor | Malignant Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Stage I Disease | Other | — | UNRESOLVED |
| Clinical Stage I with relapse, CSII Disease | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- 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.
- interventionNames
- Other: Clinical Stage I Disease
- label
- Cohort 2
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.