Can miRNA-371a-3p tell us which small testicular masses need surgery or can be watched?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study seeks to determine if miRNA-371a-3p detectable in blood or semen can identify malignant small testicular masses and guide clinical decisions between surgery and surveillance. It will retrospectively analyze banked samples and prospectively validate biomarker performance in a cohort of patients with solitary masses ≤ 2 cm. Primary goal is to see if a biomarker-based strategy can safely offer surveillance for selected patients. Secondary aims include evaluating miRNA performance across body fluids, correlating with surgical pathology, and refining assay methods toward CLIA-compliant thresholds. Endpoints include treatment-free survival, metastasis-free survival, and miRNA expression patterns in available specimens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Small testicular mass/masses ≤ 2cm

  * Patients with serum tumour marker elevation are eligible only if they are considered for surgical treatment, or if markers are felt to be falsely elevated by the physician team
  * If the patient previously had chemotherapy, the mass must first have appeared only after the treatment completed
  * The patient is at least 18 years of age
  * Ability to understand and comply with the requirements of the study
  * Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

* • Patients with testicular tumours \> 2 cm

  * Metastatic disease
  * Patients in reduced general condition, with uncontrolled intercurrent illnesses, or with life-threatening disease
  * Patients with psychiatric illnesses that would limit compliance with study requirements
  * Clinical decision is made by the multidisciplinary team that patient is not suitable for surveillance

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Robert Hamilton, MD
• Email: rob.hamilton@uhn.ca
• Phone: 416-946-2909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.