← Back to all trials
Recruiting
NCT06060873
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
Conditions: Malignant Testicular Germ Cell Tumor
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 418
Sponsor: University of Southern California
Location: University of Alabama at Birmingham Cancer Center Birmingham Alabama
Summary
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
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
* 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) \
Source: ClinicalTrials.gov (NCT06060873). StuddyBuddy aggregates publicly available trial information.