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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Robert Hamilton, MD
- Telefonnummer: 416-946-2909
- E-mail: rob.hamilton@uhn.ca
Undersøgelse Kontakt Backup
- Navn: Talha Chaudhry, MSc
- Telefonnummer: 437-221-9469
- E-mail: talha.chaudhry3@uhn.ca
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre
-
Kontakt:
- Robert Hamilton, MD
- Telefonnummer: 4169462909
- E-mail: rob.hamilton@uhn.ca
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients with small testicular masses
Beskrivelse
Inclusion Criteria:
-
• 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:
-
• 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment Free Survival (TFS)
Tidsramme: 2 years
|
Defined as the proportion of participants not requiring active treatment (RO or TSS) |
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
• Metastasis free survival (MFS)
Tidsramme: 2 years
|
length of time from date of entering the study to the date of metastasis from disease. |
2 years
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 22-5860
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