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

Malignant Testicular Germ Cell Tumor Clinical 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060873
• Other study ID #: 4T-22-2
• Secondary ID: NCI-2023-004124T
• Status: Recruiting
• Start date: June 8, 2023
• Est. completion date: December 8, 2028

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: Ileana Aldana
• Phone: 323-865-0702
• Email: Ileana.Aldana[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: December 8, 2028
• Est. primary completion date: June 8, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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), ß-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

Related Conditions & MeSH terms

• Malignant Testicular Germ Cell Tumor
• Neoplasm Metastasis
• Neoplasms, Germ Cell and Embryonal
• Testicular Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, up to 5 years