Evaluating microRNAs for diagnosing testicular cancer in small masses.
Diagnostic Role of Circulating microRNAs in Small Testicular Masses Suitable for Testis Sparing Surgery and Post-chemotherapy Residual Masses Suitable for Retroperitoneal Lymph Node Dissection.
This study is testing if certain tiny molecules in the blood can help doctors diagnose testicular cancer in adults who have small testicular masses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06620016 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic effectiveness of circulating microRNAs in identifying germ cell cancer in patients with small testicular masses or retroperitoneal residual masses following chemotherapy. The study includes two cohorts: one with patients suitable for testis-sparing surgery and another with patients eligible for retroperitoneal lymph node dissection. Participants must be adults with specific criteria regarding tumor size and serum tumor markers. The findings could enhance diagnostic accuracy and treatment planning for testicular cancer patients.
Who should consider this trial
Good fit: Ideal candidates include adults with small testicular lesions or retroperitoneal lymph node lesions who meet specific size and serum marker criteria.
Not a fit: Patients with larger tumors or those not suitable for the specified surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for detecting testicular cancer, potentially allowing for more conservative treatment options.
How similar studies have performed: While the use of microRNAs in cancer diagnostics is a growing field, this specific approach in the context of testicular cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.