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

NCT ID: NCT06060873

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 418 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-08
• Study Completion Date: 2028-12-08

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Clinical Stage I Disease

Intervention Type: 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.

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.

Clinical Stage I with relapse, CSII Disease

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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
• Suspected retroperitoneal disease: Lymphadenopathy in the retroperitoneum with 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 6 weeks of enrollment if stage II patient
• MiRNA-371 level drawn within 1 year after orchiectomy for stage I patients
• MiRNA-371 level drawn 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), β-Human Chorionic Gonadotropin (HCG), Lactate Dehydrogenase (LDH) - per the local laboratory assay <1.5xlower normal level within 42 days (6 weeks) of enrollment
• Age ≥ 16 years
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Second primary malignancy
• History of receiving chemotherapy or radiotherapy
• 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siamak Daneshmand, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2023-00412

Identifier Type: REGISTRY

Identifier Source: secondary_id

4T-22-2

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4T-22-2

Identifier Type: -

Identifier Source: org_study_id