This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
PRIMARY OBJECTIVE: I. To measure the accuracy of the blood-based biomarker miRNA-371 to predict pre-operatively 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. Patients may also have their medical records reviewed.
Study Type
OBSERVATIONAL
Enrollment
418
Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or standard surveillance. Surveillance will follow until year 5.
Patients undergo blood sample collection during screening and throughout the study. Based on results, patients will undergo a primary RPLND surgery or reassessment and then surveillance will follow until year 5.
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
RECRUITINGLoma Linda University Medical Center
Loma Linda, California, United States
RECRUITINGLos Angeles County-USC Medical Center
Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy
The positive predictive value of pre-operatively elevated miRNA-371 levels in predicting active GCT will be determined by pathologic review of RPLND specimens.
Time frame: Through study completion, up to 5 years
The 2-year disease-free survival
Estimate the 2-year disease-free survival for patients who are miRNA negative at enrollment
Time frame: Through study completion, up to 5 years
Persistence of positive postoperative miRNA as a predictor of relapse at follow-up
Evaluate the relapse rate at follow-up in patients with positive postoperative miRNA after RPLND
Time frame: Through study completion, up to 5 years
Negative predictive value of negative pre-operative miRNA
Estimate the negative predictive value of negative pre-operative miRNA as confirmed by completing 2-year surveillance or pathological confirmation (i.e. biopsy or RPLND)
Time frame: Through study completion, up to 5 years
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Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGEmory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGRutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, United States
RECRUITINGUniversity Health Network
Toronto, Ontario, Canada
RECRUITING