Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-00412 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 4T-22-2 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
This study evaluates the accuracy of blood-based biomarker testing to predict the presence of active testicular cancer.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Stage I Disease | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The 2-year disease-free survival | Estimate the 2-year disease-free survival for patients who are miRNA negative at enrollment | Through study completion, up to 5 years |
| Persistence of positive postoperative miRNA as a predictor of relapse at follow-up |
Not provided
Inclusion Criteria:
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
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:
Not provided
Not provided
Not provided
Patients with testicular germ cell tumor
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ileana Aldana | Contact | 323-865-0702 | Ileana.Aldana@med.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Siamak Daneshmand, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Recruiting | Birmingham | Alabama | 35233 | United States |
Not provided
Not provided
Not provided
Not provided
| Clinical Stage I with relapse, CSII Disease | Other | 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. |
|
Evaluate the relapse rate at follow-up in patients with positive postoperative miRNA after RPLND
| 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) | Through study completion, up to 5 years |
| Loma Linda University Medical Center | Recruiting | Loma Linda | California | 92530 | United States |
|
| Los Angeles County-USC Medical Center | Recruiting | Los Angeles | California | 90033 | United States |
|
| USC / Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
|
| Rutgers Cancer Institute of New Jersey / Jack and Sheryl Morris Cancer Center | Recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided