Health TrialsbyHealthPanel

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

ConditionMalignant Testicular Germ Cell Tumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Southern California

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)

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

Disqualifiers

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

Trial population

Patients with testicular germ cell tumor

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical Stage I Disease

    Other intervention

    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.

  • Clinical Stage I with relapse, CSII Disease

    Other intervention

    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.

Treatment groups

418 Participants
are divided into 2 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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