Testicular Germ Cell CancerNCT04914026
MicroRNA as Markers in Testicular Cancer
An observational study of Testicular Germ Cell Cancer and Seminoma, run by Haukeland University Hospital at 6 sites in 2 countries.
Trial summary
The main objective of this study is establish the performance of miR371 in management of testicular cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Testicular Germ Cell Cancer, Seminoma, Non-Seminoma Testicular Cancer
- What is being tested?
- Biomarker analysis
- How many people
- 350 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 31 Dec 2016to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with suspected and confirmed testicular germ cell cancer, aged 18-70 years. Seminomas and non-seminomas, stage I-IV.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Norway4 sites, 4 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Mette Pernille Myklebust, PhD, +47 41684492, mette.pernille.myklebust@helse-bergen.no
- Recruiting
Haugesund Hospital
Haugesund, 5528
Bogdan Stefan Bercea, MD, +47 52 73 20 00, bogdan.stefan.bercea@helse-fonna.no
- Not yet recruiting
Oslo University Hospital
Oslo, 0379
Helene Negaard, MD, PhD, +47 22 93 40 00, UXHEGA@ous-hf.no
- Recruiting
University Hospital of North Norway
Tromsø, 9038
Hege S. Haugnes, MD, PhD, +47 77 75 43 42, hege.sagstuen.haugnes@unn.no
Sweden2 sites, 2 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Anna G. Bergdahl, MD, PhD, +46 31 342 90 26, anna.grenabo@vg.region.se
- Recruiting
Karolinska University Hospital
Stockholm
Anna Thor, MD, anna.thor@ki.se
Anders Kjellman, MD, PhD, +46 073 699 52 58, anders.kjellman@sll.se
About this study
Official 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
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.
- Conditions
- Testicular Germ Cell Cancer, Seminoma, Non-Seminoma Testicular Cancer, Stage I Testicular Cancer, Stage II Testicular Cancer, Stage III Testicular Cancer
- Being tested
- Biomarker analysis
- Medical subject headings
- Testicular Neoplasms, Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker analysisOther
Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start31 Dec 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular Germ Cell CancerStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Sahlgrenska University Hospital, Helse Fonna, University Hospital of North Norway, Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Mette Pernille Myklebust, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914026
- Sponsor's protocol ID
- 2015/1475
- Status last verified
- Aug 2022
- First submitted
- 31 May 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04914026
- Acronym / sponsor ID
- 2015/1475
- Conditions
- Testicular Germ Cell Cancer, Seminoma, Non-Seminoma Testicular Cancer, Stage I Testicular Cancer, Stage II Testicular Cancer, Stage III Testicular Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Sahlgrenska University Hospital, Helse Fonna, University Hospital of North Norway, Oslo University Hospital
- Study start
- 31 Dec 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with suspected and confirmed testicular germ cell cancer, aged 18-70 years. Seminomas and non-seminomas, stage I-IV.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker analysisBlood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months | Other | – |
Primary outcome
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
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
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mette Pernille Myklebust, PhD principal investigator
Haukeland University Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Germ Cell Cancer and Seminoma, run by Haukeland University Hospital at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Pernille Myklebust, PhD (+47 41684492, mette.pernille.myklebust@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miR371 as a biomarker in testicular germ cell cancer at orchiectomy (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.