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

NCT06620016 | Recruiting

• 1 other identifier: SEARCH-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline.

Secondary Outcomes (3)

• 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.

Study Arms (2)

A

Small testicular mass suitable for testis sparing surgery.

Diagnostic Test: Circulating microRNAs.

B

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

Diagnostic Test: Circulating microRNAs.

Interventions

Circulating microRNAs. DIAGNOSTIC_TEST

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

A; B

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All males \>= 18 yo with small testicular mass suitable for testis sparing surgery or post-chemotherapy germ cell residual mass suitable for retroperitoneal lymph node dissection.

You may qualify if:

• 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.

You may not qualify if:

• None
• COHORT B:
• 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.
• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

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

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: October 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)