Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses. (SEARCH-1)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Testicular Cancer

Treatments: Diagnostic Test: Circulating microRNAs.

Study type: Observational

Funder types: Other

Identifiers

NCT06620016

SEARCH-1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion Criteria:

• None

Trial design

60 participants in 2 patient groups

A

Description:

Small testicular mass suitable for testis sparing surgery.

Treatment:

Diagnostic Test: Circulating microRNAs.

B

Description:

Retroperitoneal post-chemotherapy residual mass suitable for retroperitoneal lymph node dissection.

Treatment:

Diagnostic Test: Circulating microRNAs.