NCT06060873

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 418 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malignant Testicular Germ Cell Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-08
• Primary completion: 2028-06-08
• Completion: 2028-12-08
• First posted: 2023-09-29
• Last updated: 2026-04-13

Locations

5 sites across 1 country: United States