miRNA to Guide Appropriate Intervention of Small Testis Masses (miRSTM)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Robert Hamilton, MD
- Phone Number: 416-946-2909
- Email: rob.hamilton@uhn.ca
Study Contact Backup
- Name: Talha Chaudhry, MSc
- Phone Number: 437-221-9469
- Email: talha.chaudhry3@uhn.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Princess Margaret Cancer Centre
-
Contact:
- Robert Hamilton, MD
- Phone Number: 4169462909
- Email: rob.hamilton@uhn.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with small testicular masses
Description
Inclusion Criteria:
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• 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:
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• 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 Plan
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Free Survival (TFS)
Time Frame: 2 years
|
Defined as the proportion of participants not requiring active treatment (RO or TSS) |
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• Metastasis free survival (MFS)
Time Frame: 2 years
|
length of time from date of entering the study to the date of metastasis from disease. |
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-5860
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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