miRNA to Guide Appropriate Intervention of Small Testis Masses
ConditionTestis Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial population
Patients with small testicular masses
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Treatment Free Survival (TFS)
Defined as the proportion of participants not requiring active treatment (RO or TSS)
Time frame
2 yearsSecondary outcomes
1
• Metastasis free survival (MFS)
length of time from date of entering the study to the date of metastasis from disease.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov