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Recruiting Observational

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

NCT06620016 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-10-01
Last updated
2024-10-21

Condition(s) studied

Testicular Cancer

Investigational drug(s) / intervention(s)

Circulating microRNAs.

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06620016 on ClinicalTrials.gov ↗ ← All trials in Italy