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NCT06060873Recruiting

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

University of Southern California

Start Date

6/8/2023

Completion Date

12/8/2028

Summary

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

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Clinical Stage I Disease

OTHER

Clinical Stage I with relapse, CSII Disease

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Conditions

Malignant Testicular Germ Cell Tumor

Locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama 35233

United States

Loma Linda University Medical Center

Loma Linda, California 92530

United States

Los Angeles County-USC Medical Center

Los Angeles, California 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center

New Brunswick, New Jersey 08901

United States