Recruiting

miRNA-371a-3p

Sponsor:

University Health Network, Toronto

Code:

NCT07852871

Conditions

Testis Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study aims to determine, for the first time, if miRNA-371a-3p can be used as an accurate biomarker to identify which small (≤ 2cm) testicular masses are malignant and aid in clinical decision-making to offer surgery or surveillance. We propose a retrospective exploration of banked serum, plasma and semen specimens of men with small testis masses and a prospective biomarker-based intervention trial to validate miR-371a-3p performance.

Conditions

Testis Cancer

Study ID

NCT07852871

Start date

Jul 12, 2023

Status verified date

Sep, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Treatment Free Survival (TFS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Robert Hamilton, MD

416-946-2909rob.hamilton@uhn.ca

Talha Chaudhry, MSc

437-221-9469talha.chaudhry3@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Robert Hamilton, MD

4169462909rob.hamilton@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • small testis masses
  • microRNA
  • testis cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.