Using blood tests to detect active testicular cancer
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)
University of Southern California · NCT06060873
This study is testing if a blood test can help find active testicular cancer earlier in patients before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 418 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Southern California (other) |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT06060873 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the accuracy of the blood-based biomarker miRNA-371 in predicting the presence of active malignant testicular germ cell tumors before surgery. Patients will have blood samples collected during screening and throughout the study, with those showing elevated miRNA-371 levels proceeding to standard surgery. Those with normal levels will undergo surveillance until their levels rise. The study aims to improve pre-operative detection of testicular cancer.
Who should consider this trial
Good fit: Ideal candidates include patients with a confirmed diagnosis of testicular germ cell tumors who meet specific clinical staging criteria.
Not a fit: Patients with advanced metastatic disease or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate pre-operative detection of testicular cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using blood-based biomarkers for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 * 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 Exclusion Criteria: * 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
Where this trial is running
Birmingham, Alabama and 4 other locations
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States (RECRUITING)
- Loma Linda University Medical Center — Loma Linda, California, United States (RECRUITING)
- Los Angeles County-USC Medical Center — Los Angeles, California, United States (RECRUITING)
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
- Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center — New Brunswick, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Siamak Daneshmand, MD — University of Southern California
- Study coordinator: Ileana Aldana
- Email: Ileana.Aldana@med.usc.edu
- Phone: 323-865-0702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Testicular Germ Cell Tumor