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

NCT06060873

RecruitingN/A

Sponsor: University of Southern California

Conditions: Malignant Testicular Germ Cell Tumor

Interventions: Clinical Stage I Disease, Clinical Stage I with relapse, CSII Disease

Countries: United States, Canada

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

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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) \<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

Locations (7)

Birmingham, Alabama, United States
Loma Linda, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Atlanta, Georgia, United States
New Brunswick, New Jersey, United States
Toronto, Ontario, Canada