Testicular Cancer
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCirculating microRNAs.
Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
COHORT A: Inclusion Criteria: * Age \>= 18 years * Single testicular lesion, with \< 2 cm diameter and \< 30 % testicular volume involvement; * Negative Serum Tumour Markers; * Suitable for testis sparing surgery; * Informed consent.
Exclusion criteria
* None COHORT B: Inclusion Criteria: * Age \>= 18 years * Single/multiple post-chemotherapy retroperitoneal lymph node lesion, with \> 1 cm (non seminomatous) / \> 3 cm (seminomatous) diameter in patients with previous testicular germ cell primary tumour; * Negative Serum Tumour Markers; * Suitable for retroperitoneal lymph node dissection; * Informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MicroRNA's germ cell cancer detection (Cohort A) | Baseline. | 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. |
| MicroRNA's germ cell cancer detection (Cohort B) | Baseline. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MicroRNA's germ cell cancer subtype detection (Cohort A + B) | Baseline. | 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. |
| MicroRNA's vs Frozen Section Examination's germ cell cancer detection (Cohort A) | Baseline. | 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. |
| MicroRNA's disease recurrence/persistence detection (Cohort A + B) | Week 4. | 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. |
Countries
Italy
Outcome results
None listed