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NCT06060873 | RECRUITING | Malignant Testicular Germ Cell Tumor

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

University of Southern California

Brief Summary:

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

Condition or disease

Malignant Testicular Germ Cell Tumor

Intervention/treatment

Non-Interventional Study

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 418 participants
Official Title : 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)
Actual Study Start Date : 2023-06-08
Estimated Primary Completion Date : 2028-06-08
Estimated Study Completion Date : 2028-12-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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
    • * Suspected retroperitoneal disease: Lymphadenopathy in the retroperitoneum with no lymph node \>3 cm in greatest dimension with no more than 2 nodes enlarged
    • * Axial imaging within 6 weeks of enrollment
    • * Chest imaging (x-ray, CT or MRI) negative for metastasis within 6 weeks of enrollment
    • * MiRNA-371 level drawn at any timepoint after orchiectomy
    • * 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), β-Human Chorionic Gonadotropin (HCG), Lactate Dehydrogenase (LDH) - per the local laboratory assay \<1.5xlower normal level within 30 days of enrollment
    • * Age ≥ 16 years
    • * Eastern Cooperative Oncology Group (ECOG) performance status ≤2
    • * Ability to understand and the willingness to sign a written informed consent
    Exclusion Criteria
    • * Second primary malignancy
    • * History of receiving chemotherapy or radiotherapy
    • * 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
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial

Location Details

NCT06060873

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Locations

RECRUITING

United States, California

Los Angeles County-USC Medical Center

Los Angeles, California, United States, 90033

RECRUITING

United States, California

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033