ClinicalTrials.gg
RecruitingNCT04914026Updated Aug 8, 2022

MicroRNA as Markers in Testicular Cancer

An observational study in Testicular Germ Cell Cancer, Seminoma and Non-Seminoma Testicular Cancer, sponsored by Haukeland University Hospital. Recruiting at 6 sites in 2 countries. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-08.

Sponsored by Haukeland University Hospital · Observational

From the registry’s dates

  • Started Dec 2016; still recruiting 9 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
350
Ages
18 Years to 70 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

In context

Testicular Neoplasms

295 studies on the registry are indexed under Testicular Neoplasms; 51 are open to participants now.

This study's planned enrollment of 350 is above the median of 133 across 73 observational studies indexed under Testicular Neoplasms.

Browse Testicular Neoplasms studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Other prior or concomitant (other than testicular cancer).
  • Other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherBiomarker analysis

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

  2. 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

    Time frame: 5 years

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

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

    Time frame: 5 years

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

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

    Time frame: 5 years

07

Study locations

4 of 6 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2016 (actual). Primary completion is estimated for Dec 2026, 120 months after the start.

Of 41 observational studies under Testicular Neoplasms, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 191. This study's planned 120 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2021
First posted
Jun 4, 2021
StartActual
Dec 31, 2016
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Aug 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04914026
Responsible party
Sponsor
First posted
Jun 4, 2021
Start date
Dec 31, 2016
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 8, 2022

Study contacts

Mette Pernille Myklebust, PhD
Contact
mette.pernille.myklebust@helse-bergen.no
+47 41684492
Olav Dahl, PhD
Contact
olav.dahl@helse-bergen.no
+47 55972081
Mette Pernille Myklebust, PhD
principal investigator · Haukeland University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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