Malignant Testicular Germ Cell TumorNCT06060873
MAGESTIC Trial: MiRNA in Detecting Active Germ Cell Tumors in Early Suspected and MetastaTIC Disease Trial
An observational study of Malignant Testicular Germ Cell Tumor, run by University of Southern California at 7 sites in 2 countries.
Trial summary
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Malignant Testicular Germ Cell Tumor
- What is being tested?
- Clinical Stage I Disease and Clinical Stage I with relapse, CSII Disease
- How many people
- 418 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 8 Jun 2023to 8 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with testicular germ cell tumor
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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 locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Sophie Kim, 404-778-4898, sophie.kim@emory.edu
Sierra Thomson, 404-778-4898, sierra.williams@emory.edu
- Recruiting
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Alisha Hitt, 205-539-2908, aghitt@uabmc.edu
Charles Peyton, MD
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92530
Tiffany Sanchez, 909-558-7251, TISanchez@llu.edu
Alsyouf Muhannad, MD
- Recruiting
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
Ileana Aldana, 323-865-0702, Ileana.Aldana@med.usc.edu
Siamak Daneshmand, MD
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Ileana Aldana, MD, 323-865-0702, Ileana.Aldana@med.usc.edu
Siamak Daneshmand, MD
- Recruiting
Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center
New Brunswick, New Jersey, 08901
Alicia Moore, 732-609-1144, aca108@cinj.rutgers.edu
Thomas Jang, MA
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Rida Khan, (416) 946-4501 ext. 2282, rida.khan2@uhn.ca
Stephen Cox, stephen.cox3@uhn.ca
About this study
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)
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Malignant Testicular Germ Cell Tumor
- Being tested
- Clinical Stage I Disease, Clinical Stage I with relapse, CSII Disease
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Stage I DiseaseOther
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 DiseaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | This cohort involves all CS-I GCT patients which is defined as GCT in orchiectomy specimen (seminoma and NSGCT), normal conventional staging imaging, and normal/low stable tumor markers. The current standard of care for management of CS-I disease is either surveillance, RPLND, or systemic therapy. Surveillance is preferred however is largely dependent on clinician discretion. In this cohort miRNA-371 level will be drawn at any timepoint after orchiectomy. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years. Receives: Other: Clinical Stage I Disease | |
| Cohort 2 | This cohort involves all GCT patients with radiographically enlarged retroperitoneal lymph nodes <3 cm (initial CS-I GCT patients with radiographic evidence of retroperitoneal lymph node enlargement and de-novo CS-II patients). In this cohort, miRNA-371 level will be drawn at any timepoint after orchiectomy. Patients with initial CS-I and retroprertioneal relapse/ de-novo CS-II disease and normal miRNA-371 levels will undergo reassessment (repeat cross sectional imaging and miRNA level) after 6 weeks. If mass is stable and miRNA-371 level remains normal then patients will continue on surveillance. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years. Receives: Other: Clinical Stage I with relapse, CSII Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 5 years
Secondary outcomes (3)
The 2-year disease-free survival
Estimate the 2-year disease-free survival for patients who are miRNA negative at enrollment
Measured: Through study completion, up to 5 years
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
Measured: Through study completion, up to 5 years
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)
Measured: Through study completion, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start8 Jun 2023
- Primary completion8 Jun 2028 (estimated)
- Study completion8 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Testicular Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Siamak Daneshmand, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060873
- Sponsor's protocol ID
- 4T-22-2
- Other IDs
- NCI-2023-00412, 4T-22-2, P30CA014089
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06060873
- Acronym / sponsor ID
- 4T-22-2
- Conditions
- Malignant Testicular Germ Cell Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 8 Jun 2028 (estimated)
- Study completion
- 8 Dec 2028 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
Detailed description
PRIMARY OBJECTIVE:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Clinical Stage I DiseaseThis cohort involves all CS-I GCT patients which is defined as GCT in orchiectomy specimen (seminoma and NSGCT), normal conventional staging imaging, and normal/low stable tumor markers. The current standard of care for management of CS-I disease is either surveillance, RPLND, or systemic therapy. Surveillance is preferred however is largely dependent on clinician discretion. In this cohort miRNA-371 level will be drawn at any timepoint after orchiectomy. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years. |
| Cohort 2 | – | Other: Clinical Stage I with relapse, CSII DiseaseThis cohort involves all GCT patients with radiographically enlarged retroperitoneal lymph nodes <3 cm (initial CS-I GCT patients with radiographic evidence of retroperitoneal lymph node enlargement and de-novo CS-II patients). In this cohort, miRNA-371 level will be drawn at any timepoint after orchiectomy. Patients with initial CS-I and retroprertioneal relapse/ de-novo CS-II disease and normal miRNA-371 levels will undergo reassessment (repeat cross sectional imaging and miRNA level) after 6 weeks. If mass is stable and miRNA-371 level remains normal then patients will continue on surveillance. Patient will continue to be followed with miRNA levels with each conventional marker draw until 2 years, and followed according to standard of care guidelines until 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with testicular germ cell tumor
Key inclusion criteria (15 listed)
- Primary tumor excised by radical inguinal orchiectomy and pathology consistent with GCT (seminoma or NSGCT)
- Clinical stage of patient is either:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Stage I DiseasePatients 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. | Other | Cohort 1 |
| Clinical Stage I with relapse, CSII DiseasePatients 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. | Other | Cohort 2 |
Primary outcome
Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy
Time frame: Through study completion, up to 5 years
The positive predictive value of pre-operatively elevated miRNA-371 levels in predicting active GCT will be determined by pathologic review of RPLND specimens.
3 secondary outcomes
The 2-year disease-free survival
Time frame: Through study completion, up to 5 years
Persistence of positive postoperative miRNA as a predictor of relapse at follow-up
Time frame: Through study completion, up to 5 years
Negative predictive value of negative pre-operative miRNA
Time frame: Through study completion, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siamak Daneshmand, MD principal investigator
University of Southern California
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Testicular Germ Cell Tumor, run by University of Southern California at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ileana Aldana (323-865-0702, Ileana.Aldana@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of miRNA-371 to predict pre-operatively the presence of active germ cell malignancy (time frame: Through study completion, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.