MicroRNA as Markers in Testicular Cancer

Recruiting

• Conditions: Stage III Testicular Cancer; Relapse Testicular Cancer; Non-Seminoma Testicular Cancer; Stage I Testicular Cancer; Testicular Germ Cell Cancer; Stage II Testicular Cancer; Stage IV Testicular Cancer; Seminoma

• Registration Number: NCT04914026
• Lead Sponsor: Haukeland University Hospital

Brief Summary

The main objective of this study is establish the performance of miR371 in management of testicular cancer

Detailed Description

The main objective of the study is to asses the sensitivity and specificity of microRNA-371a-5p (miR371) in detection of viable testicular germ tumour cells. To assess the utility of miR371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.

Study Timeline

• Study Start: 2016-12-31
• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 350

Inclusion Criteria

• Patients with suspected testicular cancer, referred to orchiectomy.
• Patients diagnosed with testicular germ cell cancer.
• Age 18-70 years of age.
• Must be able receive information and to consent.

Exclusion Criteria

• Other prior or concomitant malignancy (other than testicular cancer).
• Other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment	5 years	To estimate the performance of miR371 in monitoring of treatment efficiency (chemotherapy)
miR371 as a biomarker in testicular germ cell cancer and detection of recurrence	5 years	To estimate the performance of miR371 in (early) detection of recurrence
miR371 as a biomarker in testicular germ cell cancer at orchiectomy	5 years	To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at diagnosis
miR371 as a biomarker in testicular germ cell cancer at RPLND	5 years	To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at RPLND

Trial Locations

Locations (6)

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Haugesund Hospital; 🇳🇴 Haugesund, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway