MicroRNA as Markers in Testicular Cancer

NCT ID: NCT04914026

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biomarker analysis

Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mette Pernille Myklebust, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Haugesund Hospital

Haugesund, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status NOT_YET_RECRUITING

University Hospital of North Norway

Tromsø, , Norway

Site Status RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status NOT_YET_RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mette Pernille Myklebust, PhD

Role: CONTACT

+47 41684492

Olav Dahl, PhD

Role: CONTACT

+47 55972081

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mette Pernille Myklebust, PhD

Role: primary

+47 41684492

Bogdan Stefan Bercea, MD

Role: primary

+47 52 73 20 00

Helene Negaard, MD, PhD

Role: primary

+47 22 93 40 00

Hege S. Haugnes, MD, PhD

Role: primary

+47 77 75 43 42

Anna G. Bergdahl, MD, PhD

Role: primary

+46 31 342 90 26

Anna Thor, MD

Role: primary

Anders Kjellman, MD, PhD

Role: backup

+46 073 699 52 58

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015/1475

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MicroRNA Markers in Head and Neck Cancers
NCT04305366 ACTIVE_NOT_RECRUITING