Testicular Germ Cell Cancer, Seminoma, Non-Seminoma Testicular Cancer, Stage I Testicular Cancer, Stage II Testicular Cancer, Stage III Testicular Cancer, Stage IV Testicular Cancer, Relapse Testicular Cancer
Conditions
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.
Interventions
OTHERBiomarker analysis
Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months
Sponsors
Karolinska University Hospital
Sahlgrenska University Hospital
Helse Fonna
University Hospital of North Norway
Oslo University Hospital
Haukeland University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Norway, Sweden
Contacts
Primary ContactMette Pernille Myklebust, PhD
Backup ContactOlav Dahl, PhD
Outcome results
None listed