[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658503":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":20,"studyPopulation":21,"armGroups":17,"interventions":17,"overallOfficials":17,"centralContacts":22,"locations":32,"responsibleParty":50,"collaborators":17,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":17,"enrollmentInfo":62,"targetDuration":17,"studyType":65,"phases":17,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":35,"whyStopped":17,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment Free Survival (TFS)","Defined as the proportion of participants not requiring active treatment (RO or TSS)","2 years",[14],{"measure":15,"description":16,"timeFrame":12},"• Metastasis free survival (MFS)","length of time from date of entering the study to the date of metastasis from disease.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":6,"timePerspective":19,"maskingInfo":17},"PROSPECTIVE","Study Intervention:\n\nBlinded measurement of miRNA expression in blood and\u002For 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.\n\nPrimary Objective: To determine if surveillance can be offered as a biomarker-based strategy to patients with solitary small testicular masses (STMs) ≤ 2cm.\n\nSecondary 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.\n\n2)To determine the association between miRNA and the presence of testicular cancer in radical or partial orchiectomy surgical specimens.\n\n3)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).\n\n4)Refining analytic methods in miRNA assessment by inter-lab comparison, determining best practices and optimal cut-offs to develop a CLIA-approved assay.\n\n5)To establish an optimal threshold for considering an incidentally found testis mass as a small testicular mass.\n\nEndpoints of the study:\n\n* Treatment free survival (TFS) for those on surveillance\n* Metastasis free survival (MFS)\n* Expression of miRNA in serum\u002Fplasma and\u002For seminal plasma in patients with STMs\n* Correlation between secretion of miRNA in STMs and GCTs or GCNIS identified in subsequent pathologic examination of surgical specimens or biopsy\n* Percentage of patients that can avoid surgery or intervention\n* Establishing an optimal surveillance protocol for patients with STMs\n* Quality of Life and anxiety in patients undergoing surveillance compared with patients undergoing active treatment\n* Expression of miRNA in patients with infertility and testicular tumours in serum\u002Fplasma and\u002For seminal plasma","Patients with small testicular masses",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":17,"email":27},"Robert Hamilton, MD","CONTACT","416-946-2909","rob.hamilton@uhn.ca",{"name":29,"role":25,"phone":30,"phoneExt":17,"email":31},"Talha Chaudhry, MSc","437-221-9469","talha.chaudhry3@uhn.ca",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Princess Margaret Cancer Centre","RECRUITING","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":42,"coordinates":43},"Point",[44,45],-79.39864,43.70643,{"lat":45,"lon":44},[48],{"name":24,"role":25,"phone":49,"phoneExt":17,"email":27},"4169462909",{"type":51,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100658503","mirna-to-guide-appropriate-intervention-of-small-testis-masses-100658503",false,"NCT07852871","miRNA to Guide Appropriate Intervention of Small Testis Masses","miRNA as a Liquid Biomarker to Guide Early Detection and Appropriate Intervention of Incidentally Detected Small Testicular Masses","miRSTM","Inclusion Criteria:\n\n* • Small testicular mass\u002Fmasses ≤ 2cm\n\n  * 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\n  * If the patient previously had chemotherapy, the mass must first have appeared only after the treatment completed\n  * The patient is at least 18 years of age\n  * Ability to understand and comply with the requirements of the study\n  * Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* • Patients with testicular tumours \\> 2 cm\n\n  * Metastatic disease\n  * Patients in reduced general condition, with uncontrolled intercurrent illnesses, or with life-threatening disease\n  * Patients with psychiatric illnesses that would limit compliance with study requirements\n  * Clinical decision is made by the multidisciplinary team that patient is not suitable for surveillance","MALE","18 Years",{"count":63,"type":64},100,"ESTIMATED","OBSERVATIONAL","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.",[68],"Testis Cancer",[70,71,72],"small testis masses","microRNA","testis cancer","2026-09-25",{"date":75,"type":76},"2026-10-01","ACTUAL",{"date":78,"type":76},"2023-07-12",{"date":80,"type":64},"2027-02",{"name":5,"class":6},1]