Clinical trial NCT06060873: MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Testicular Germ Cell Tumor
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-09-29
Enrollment: 418
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with testicular germ cell tumor

Brief 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: 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

Primary outcomes:
measure: Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy
timeFrame: Through study completion, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Siamak Daneshmand, MD
role: PRINCIPAL_INVESTIGATOR
References: