Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses.

Recruiting

• Conditions: Testicular Cancer
• Interventions: Diagnostic Test: Circulating microRNAs.

• Registration Number: NCT06620016
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-26
• Study Start: 2024-10-01
• Study First Posted: 2024-10-01
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21
• Primary Completion: 2027-09-30
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Exclusion Criteria:

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Circulating microRNAs.	Small testicular mass suitable for testis sparing surgery.
B	Circulating microRNAs.	Retroperitoneal post-chemotherapy residual mass suitable for retroperitoneal lymph node dissection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola; 🇮🇹 Bologna, Italy