MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial

Conditions

• Malignant Testicular Germ Cell Tumor

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Clinical Stage I Disease — OTHER
  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.
• Clinical Stage I with relapse, CSII Disease — OTHER
  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.

Study Details

This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.

Key Dates

Start date

Jun 8, 2023

Status verified

Apr 2026

Primary completion

Jun 8, 2028

Completion

Dec 8, 2028

Study Design

Enrollment

418 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy [ Time Frame: Through study completion, up to 5 years ]

Central Contacts

• Ileana Aldana
  323-865-0702
  [email protected]

Locations (5)

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