miRNA to Guide Appropriate Intervention of Small Testis Masses

NCT07852871 | Recruiting

• 1 other identifier: 22-5860
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

small testis masses; microRNA; testis cancer

Outcome Measures

Primary Outcomes (1)

• Treatment Free Survival (TFS)

  Defined as the proportion of participants not requiring active treatment (RO or TSS)

  2 years

Secondary Outcomes (1)

• • Metastasis free survival (MFS)

  2 years

Eligibility Criteria

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

Study Population

Patients with small testicular masses

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

MicroRNA

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

Central Study Contacts

Robert Hamilton, MD

CONTACT

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

Talha Chaudhry, MSc

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: July 12, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

CA (1)