Testis CancermiRSTMNCT07852871
miRNA to Guide Appropriate Intervention of Small Testis Masses
An observational study of Testis Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Testis Cancer
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2023to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with small testicular masses
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Robert Hamilton, MD, 4169462909, rob.hamilton@uhn.ca
About this study
Official title: miRNA as a Liquid Biomarker to Guide Early Detection and Appropriate Intervention of Incidentally Detected Small Testicular Masses
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.
Read the detailed description
Study Intervention:
Blinded measurement of miRNA expression in blood and/or seminal plasma after the decision of treatment choice has been made. Participants will undergo usual clinical care and follow a program of surveillance or surgical removal based on a clinician and patient shared decision.
Primary Objective: To determine if surveillance can be offered as a biomarker-based strategy to patients with solitary small testicular masses (STMs) ≤ 2cm.
Secondary Objectives: 1)To assess the performance characteristics of serum, plasma, and seminal plasma miRNA in a prospectively collected cohort of patients presenting with solitary masses small testicular masses ≤ 2cm.
2)To determine the association between miRNA and the presence of testicular cancer in radical or partial orchiectomy surgical specimens.
3)To evaluate surveillance as a treatment strategy in patients with STMs, negative serum tumour markers and negative miRNA secretion, assessing treatment-free survival (TFS) and metastasis free survival (MFS).
4)Refining analytic methods in miRNA assessment by inter-lab comparison, determining best practices and optimal cut-offs to develop a CLIA-approved assay.
5)To establish an optimal threshold for considering an incidentally found testis mass as a small testicular mass.
Endpoints of the study:
- Treatment free survival (TFS) for those on surveillance
- Metastasis free survival (MFS)
- Expression of miRNA in serum/plasma and/or seminal plasma in patients with STMs
- Correlation between secretion of miRNA in STMs and GCTs or GCNIS identified in subsequent pathologic examination of surgical specimens or biopsy
- Percentage of patients that can avoid surgery or intervention
- Establishing an optimal surveillance protocol for patients with STMs
- Quality of Life and anxiety in patients undergoing surveillance compared with patients undergoing active treatment
- Expression of miRNA in patients with infertility and testicular tumours in serum/plasma and/or seminal plasma
- Conditions
- Testis Cancer
- Keywords
- small testis masses, microRNA, testis cancer
- Medical subject headings
- Testicular Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Free Survival (TFS)
Defined as the proportion of participants not requiring active treatment (RO or TSS)
Measured: 2 years
Secondary outcomes (1)
• Metastasis free survival (MFS)
length of time from date of entering the study to the date of metastasis from disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start12 Jul 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testis CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852871
- Sponsor's protocol ID
- 22-5860
- Acronym
- miRSTM
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miRNA as a Liquid Biomarker to Guide Early Detection and Appropriate Intervention of Incidentally Detected Small Testicular Masses
- ClinicalTrials.gov ID
- NCT07852871
- Acronym / sponsor ID
- miRSTM / 22-5860
- Conditions
- Testis Cancer
- Keywords
- small testis masses, microRNA, testis cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Intervention:
Blinded measurement of miRNA expression in blood and/or seminal plasma after the decision of treatment choice has been made. Participants will undergo usual clinical care and follow a program of surveillance or surgical removal based on a clinician and patient shared decision.
Primary Objective: To determine if surveillance can be offered as a biomarker-based strategy to patients with solitary small testicular masses (STMs) ≤ 2cm.
Secondary Objectives: 1)To assess the performance characteristics of serum, plasma, and seminal plasma miRNA in a prospectively collected cohort of patients presenting with solitary masses small testicular masses ≤ 2cm.
2)To determine the association between miRNA and the presence of testicular cancer in radical or partial orchiectomy surgical specimens.
3)To evaluate surveillance as a treatment strategy in patients with STMs, negative serum tumour markers and negative miRNA secretion, assessing treatment-free survival (TFS) and metastasis free survival (MFS).
4)Refining analytic methods in miRNA assessment by inter-lab comparison, determining best practices and optimal cut-offs to develop a CLIA-approved assay.
5)To establish an optimal threshold for considering an incidentally found testis mass as a small testicular mass.
Endpoints of the study:
- Treatment free survival (TFS) for those on surveillance
- Metastasis free survival (MFS)
- Expression of miRNA in serum/plasma and/or seminal plasma in patients with STMs
- Correlation between secretion of miRNA in STMs and GCTs or GCNIS identified in subsequent pathologic examination of surgical specimens or biopsy
- Percentage of patients that can avoid surgery or intervention
- Establishing an optimal surveillance protocol for patients with STMs
- Quality of Life and anxiety in patients undergoing surveillance compared with patients undergoing active treatment
- Expression of miRNA in patients with infertility and testicular tumours in serum/plasma and/or seminal plasma
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with small testicular masses
Key inclusion criteria (6 listed)
- • Small testicular mass/masses ≤ 2cm
Key exclusion criteria (5 listed)
- • Patients with testicular tumours > 2 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Free Survival (TFS)
Time frame: 2 years
Defined as the proportion of participants not requiring active treatment (RO or TSS)
1 secondary outcome
• Metastasis free survival (MFS)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testis Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Hamilton, MD (416-946-2909, rob.hamilton@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Free Survival (TFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.