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

NCT06060873 | Recruiting DMC

• 3 other identifiers: 4T-22-2NCI-2023-00412P30CA014089
• Study Type: observational
• Target: 418
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Malignant Testicular Germ Cell Tumor

Outcome Measures

Primary Outcomes (1)

• Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy

  The positive predictive value of pre-operatively elevated miRNA-371 levels in predicting active GCT will be determined by pathologic review of RPLND specimens.

  Through study completion, up to 5 years

Secondary Outcomes (3)

• The 2-year disease-free survival

  Through study completion, up to 5 years

• Persistence of positive postoperative miRNA as a predictor of relapse at follow-up

  Through study completion, up to 5 years

• Negative predictive value of negative pre-operative miRNA

  Through study completion, up to 5 years

Study Arms (2)

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.

Other: Clinical Stage I Disease

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.

Other: Clinical Stage I with relapse, CSII Disease

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.

Cohort 1

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.

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with testicular germ cell tumor

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

Loma Linda University Medical Center

Loma Linda, California, 92530, United States

RECRUITING

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Siamak Daneshmand, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ileana Aldana

CONTACT

323-865-0702; Ileana.Aldana@med.usc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: June 8, 2023
• Primary Completion (Estimated): June 8, 2028
• Study Completion (Estimated): December 8, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (5)