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The purpose of this study is to evaluate the diagnostic performance of circulating microRNAs in detecting the presence of germ cell cancer in patients with small testicular mass or retroperitoneal post-chemotherapy residual mass and suitable for testis sparing surgery and retroperitoneal lymph node dissection, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Small testicular mass suitable for testis sparing surgery. |
| |
| B | Retroperitoneal post-chemotherapy residual mass suitable for retroperitoneal lymph node dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circulating microRNAs. | Diagnostic Test | Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MicroRNA's germ cell cancer detection (Cohort A) | Preoperative circulating microRNA's diagnostic accuracy in detecting germ cell cancer in patients with small testicular mass and submitted to testis sparing surgery, using post-operative surgical specimen as reference. | Baseline. |
| MicroRNA's germ cell cancer detection (Cohort B) | Preoperative circulating microRNA's diagnostic accuracy in detecting germ cell cancer in patients with post-chemotherapy residual mass and submitted to retroperitoneal lymph node dissection, using post-operative surgical specimen as reference. | Baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| MicroRNA's germ cell cancer subtype detection (Cohort A + B) | Preoperative circulating microRNA's diagnostic accuracy in detecting seminomatous and non-seminomatous germ cell cancer in patients with small testicular mass/post-chemotherapy residual mass and submitted to testis sparing surgery/retroperitoneal lymph node dissection, using post-operative surgical specimen as reference. | Baseline. |
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COHORT A:
Inclusion Criteria:
Exclusion Criteria:
COHORT B:
Inclusion Criteria:
Exclusion Criteria:
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All males >= 18 yo with small testicular mass suitable for testis sparing surgery or post-chemotherapy germ cell residual mass suitable for retroperitoneal lymph node dissection.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola | Recruiting | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
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| MicroRNA's vs Frozen Section Examination's germ cell cancer detection (Cohort A) | Comparison between preoperative circulating microRNA and Frozen Section Examination in detecting germ cell cancer in patients with small testicular mass and submitted to testis sparing surgery, using post-operative surgical specimen as reference. | Baseline. |
| MicroRNA's disease recurrence/persistence detection (Cohort A + B) | Postoperative circulating microRNA's diagnostic accuracy in detecting disease recurrence/persistence in patients with small testicular mass/post-chemotherapy residual mass and submitted to testis sparing surgery/retroperitoneal lymph node dissection, using post-operative radiological imaging as reference. | Week 4. |
| 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 |