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Phase II Trial of Serum Micro RNA-371 in Detecting Active Germ Cell Tumors in Patients with Suspected Regional Disease - (MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial)
Trial Status: active
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
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 AFP < 50 ng/ml, β-HCG < 25 mIU/ml level 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06060873.
I. To measure the accuracy of the blood-based biomarker miRNA-371 to predict the presence of active germ cell malignancy.
OUTLINE: This is an observational study.
Patients undergo blood sample collection during screening and throughout the study. Patients whose screening blood samples show elevated miRNA-371 proceed to standard RPLND surgery. Patients whose screening blood samples show normal levels of miRNA-371 undergo standard surveillance followed by standard RPLND surgery at the time of elevated miRNA-371 levels or increase in retroperitoneal mass size. Patients may also have their medical records reviewed.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUSC / Norris Comprehensive Cancer Center