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

N/ARecruitingNCT06620016

IRCCS Azienda Ospedaliero-Universitaria di Bologna60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Testicular Cancer

Interventions

Circulating microRNAs.DIAGNOSTIC_TEST

Pre and post-surgery evaluation of peripheral blood circulating microRNAs levels.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * None

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola

Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline.

Secondary Outcomes

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.

Time frame: Baseline.

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.

Time frame: 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.

Data from ClinicalTrials.gov

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