Diagnostic Role of Circulating microRNAs in Small Testicular Masses Suitable for Testis Sparing Surgery and Post-chemotherapy Residual Masses Suitable for Retroperitoneal Lymph Node Dissection.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- MicroRNA's germ cell cancer detection (Cohort A)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •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.
- •Exclusion Criteria:
Outcomes
Primary Outcomes
MicroRNA's germ cell cancer detection (Cohort A)
Time Frame: 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)
Time Frame: 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 Outcomes
- MicroRNA's germ cell cancer subtype detection (Cohort A + B)(Baseline.)
- MicroRNA's vs Frozen Section Examination's germ cell cancer detection (Cohort A)(Baseline.)
- MicroRNA's disease recurrence/persistence detection (Cohort A + B)(Week 4.)