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NCT Number: NCT04914026

MicroRNA as Markers in Testicular Cancer

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

Recruiting

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Key information

Conditions

Testicular Germ Cell Cancer Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Germinoma Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Non-Seminoma Testicular Cancer Relapse Testicular Cancer Seminoma Stage I Testicular Cancer Stage II Testicular Cancer Stage III Testicular Cancer Stage IV Testicular Cancer Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomarker Analysis

Other

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

Primary outcomes

  1. miR371 as a biomarker in testicular germ cell cancer at orchiectomy

    Time frame: 5 years

    To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at diagnosis

  2. miR371 as a biomarker in testicular germ cell cancer at RPLND

    Time frame: 5 years

    To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at RPLND

  3. miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment

    Time frame: 5 years

    To estimate the performance of miR371 in monitoring of treatment efficiency (chemotherapy)

  4. miR371 as a biomarker in testicular germ cell cancer and detection of recurrence

    Time frame: 5 years

    To estimate the performance of miR371 in (early) detection of recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Mette Pernille Myklebust, PhD

CONTACT

[email protected]

+47 41684492

Olav Dahl, PhD

CONTACT

[email protected]

+47 55972081

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helse Fonna
  • Karolinska University Hospital
  • Oslo University Hospital
  • Sahlgrenska University Hospital
  • University Hospital of North Norway

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2021
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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