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)

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

Study Overview

• Status: Recruiting
• Conditions: Malignant Testicular Germ Cell Tumor
• Intervention / Treatment: Other: Clinical Stage I Disease; Other: Clinical Stage I with relapse, CSII Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 418

Contacts and Locations

• Study Contact: Name: Ileana Aldana; Phone Number: 323-865-0702; Email: Ileana.aldana@med.usc.edu

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • University Health Network
      • Contact: Rida Khan; Phone Number: 2282 (416) 946-4501; Email: rida.khan2@uhn.ca
      • Contact: Stephen Cox; Email: stephen.cox3@uhn.ca
      • Principal Investigator: Robert Hamilton, MD
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham Cancer Center
      • Principal Investigator: Charles Peyton, MD
      • Contact: Alisha Hitt; Phone Number: 205-539-2908; Email: aghitt@uabmc.edu
  • California
    • Loma Linda, California, United States, 92530
      • Recruiting
      • Loma Linda University Medical Center
      • Contact: Tiffany Sanchez; Phone Number: 909-558-7251; Email: TISanchez@llu.edu
      • Principal Investigator: Alsyouf Muhannad, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Principal Investigator: Siamak Daneshmand, MD
      • Contact: Ileana Aldana, MD; Phone Number: 323-865-0702; Email: Ileana.Aldana@med.usc.edu
      • Sub-Investigator: Muhannad Alsyouf, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles County-USC Medical Center
      • Contact: Ileana Aldana; Phone Number: 323-865-0702; Email: Ileana.aldana@med.usc.edu
      • Principal Investigator: Siamak Daneshmand, MD
      • Sub-Investigator: Muhannad Alsyouf, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital/Winship Cancer Institute
      • Principal Investigator: Viraj Master, MD
      • Contact: Sophie Kim; Phone Number: 404-778-4898; Email: sophie.kim@emory.edu
      • Contact: Sierra Thomson; Phone Number: 404-778-4898; Email: sierra.williams@emory.edu
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center
      • Contact: Alicia Moore; Phone Number: 732-609-1144; Email: aca108@cinj.rutgers.edu
      • Principal Investigator: Thomas Jang, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with testicular germ cell tumor

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 2-year disease-free survival	Estimate the 2-year disease-free survival for patients who are miRNA negative at enrollment	Through study completion, up to 5 years
Persistence of positive postoperative miRNA as a predictor of relapse at follow-up	Evaluate the relapse rate at follow-up in patients with positive postoperative miRNA after RPLND	Through study completion, up to 5 years
Negative predictive value of negative pre-operative miRNA	Estimate the negative predictive value of negative pre-operative miRNA as confirmed by completing 2-year surveillance or pathological confirmation (i.e. biopsy or RPLND)	Through study completion, up to 5 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Siamak Daneshmand, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): June 8, 2028
• Study Completion (Estimated): December 8, 2028

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Endocrine Gland Neoplasms; Gonadal Disorders; Testicular Diseases; Testicular Neoplasms
• Other Study ID Numbers: 4T-22-2 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2023-00412 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No