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

Summary

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

Eligibility

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

Conditions2

Locations6 sites

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