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

Recruiting now

Conditions studied: Malignant Testicular Germ Cell Tumor

In brief

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

Key facts

Study ID

NCT06060873

Run by

University of Southern California

People needed

418

Starts

2023-06-08

Expected to finish

2028-12-08

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (enrolling)
• Loma Linda University Medical Center — Loma Linda, California, United States (enrolling)
• Los Angeles County-USC Medical Center — Los Angeles, California, United States (enrolling)
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center — New Brunswick, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.