NCT04914026

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Dec 2016Dec 2026

Study Start

First participant enrolled

December 31, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

10 years

First QC Date

May 31, 2021

Last Update Submit

August 5, 2022

Conditions

Testicular Germ Cell CancerSeminomaNon-Seminoma Testicular CancerStage I Testicular CancerStage II Testicular CancerStage III Testicular CancerStage IV Testicular CancerRelapse Testicular Cancer

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Interventions

Biomarker analysisOTHER

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

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTesticular Germ Cell Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men with suspected and confirmed testicular germ cell cancer, aged 18-70 years. Seminomas and non-seminomas, stage I-IV.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Haugesund Hospital

Haugesund, 5528, Norway

RECRUITING

Oslo University Hospital

Oslo, 0379, Norway

NOT YET RECRUITING

University Hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood is collected in order to extract RNA.

MeSH Terms

Conditions

Testicular NeoplasmsSeminoma

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersGerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Study Officials

  • Mette Pernille Myklebust, PhD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Pernille Myklebust, PhD

CONTACT

+47 41684492mette.pernille.myklebust@helse-bergen.no

Olav Dahl, PhD

CONTACT

+47 55972081olav.dahl@helse-bergen.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 4, 2021

Study Start

December 31, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

NO(4)SE(2)