MicroRNA as Markers in Testicular Cancer

Seminoma Clinical Trial

Official title:

MicroRNA-371 as Markers for Disease Activity and as a Tool to Monitor the Effect of Chemotherapy and Early Detection of Recurrence in Patients With Testicular Germ Cell Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914026
• Other study ID #: 2015/1475
• Status: Recruiting
• Start date: December 31, 2016
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2022
• Source: Haukeland University Hospital
• Contact: Mette Pernille Myklebust, PhD
• Phone: +47 41684492
• Email: mette.pernille.myklebust[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Seminoma
• Stage III Testicular Cancer
• Testicular Germ Cell Cancer
• Testicular Neoplasms

Intervention

Other:
• Biomarker analysis
Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Haugesund Hospital	Haugesund
Norway	Oslo University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Karolinska University Hospital	Stockholm

Sponsors (6)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Fonna, Karolinska University Hospital, Oslo University Hospital, Sahlgrenska University Hospital, Sweden, University Hospital of North Norway

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

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