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

Recruitingn/aAges 18 Years - anyMaleUniversity of Southern California
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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, ฮฒ-Human Chorionic Gonadotropin (ฮฒ-HCG) 25 mIU/ml within 42 days (6 weeks) of enrollment * Age โ‰ฅ 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
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What it tests

  • Clinical Stage I Disease
  • Clinical Stage I with relapse, CSII Disease
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Where

7 sites
University of Alabama at Birmingham Cancer Center
Birmingham, United States
Loma Linda University Medical Center
Loma Linda, United States
Los Angeles County-USC Medical Center
Los Angeles, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center
New Brunswick, United States
University Health Network
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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