Prostate CancerNCT03896178
Prostate Cancer in Firemen: Early Diagnosis Because of Increased Diagnostic Pressure?
An observational study of Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Firefighters, police, military personnel and pilots are all shown to have a higher incidence of prostate cancer than the general population. A possible explanation for this is that these four groups of employees need regular mandatory health-checkups. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- None, observational study
- How many people
- 137,536 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2020to 2 Feb 2020
- How long will I take part?
- 60 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All men registered in the Cancer Registry of Norway with prostate cancer. Analysis of firefighters, pilots, police, military personnel and a matched group of other workers.
Who may be able to join
- All cases of prostate cancer as registered by the Cancer Registry of Norway
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of Prostate Cancer in Firefighters - a Register-based Study of Prognostic Factors and Survival
Firefighters, police, military personnel and pilots are all shown to have a higher incidence of prostate cancer than the general population. A possible explanation for this is that these four groups of employees need regular mandatory health-checkups. If these checkups increase the chances of having a PSA or DRE performed one could expect the workers in question to have a higher probability than the general population of being diagnosed with prostate cancer. If this is the case the four groups should have cancers that are lower grade and have better survival. The investigators wish to examine this by comparing the four groups with a control group made up of all other workers with regards to prognostic factors at the time of diagnosis and survival rates. This will be done by extracting data from the Cancer Registry of Norway, coupled with employment data from Statistics Norway. This study is also a part of a project on cancer in firefighters. If the prostate cancers in firefighters differ significantly from the other three specified groups, this could point to an exposure specific for firefighters, e.g. fire smoke, as an etiologic factor.
- Conditions
- Prostate Cancer
- Being tested
- None, observational study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, observational studyOther
None, observational study
| Study group | Role | What they receive |
|---|---|---|
| Firefighters | Not described Receives: Other: None, observational study | |
| Pilots | Not described Receives: Other: None, observational study | |
| Police | Not described Receives: Other: None, observational study | |
| Military personnel | Not described Receives: Other: None, observational study | |
| Controls | Control group matched for geographic location (county), and year of diagnosis. Consisting of all other workers than the four specified groups. Receives: Other: None, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause-specific mortality rate for prostate cancer
Measured: From January 1st 1960 until December 31st 2018
Secondary outcomes (4)
TNM staging
Measured: January 1st 1960 until December 31st 2018
Gleason score
Score based on microscopic appearance of prostate cancer tissue. Sum of two scores, each ranging from 1-5 (only whole numbers), meaning the final score ranges from 2-10. A higher score is associated with a more aggressive/less differentiated tumor. It is normal to group scores 2-6 together in >7. It is also normal to differentiate between 7 (4+3) (worse), and 7 (3+4) (better).
Measured: January 1st 1960 until December 31st 2018
PSA at time of diagnosis
Measured: January 1st 1960 until December 31st 2018
Functional status at time of diagnosis (WHO classification)
Measured: January 1st 1960 until December 31st 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Feb 2020
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Case only
- Time perspective
- Other
- Enrolment
- 137,536 participants (actual)
- Target duration
- 60 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Extrastiftelsen, National Institute for Occupational Safety and Health (NIOSH/CDC), Norwegian Confederation of Trade Unions, Fagforbundet, Gjensidige Foundation, Norwegian Cancer Society, Norwegian Firefighters Fight Cancer, Norwegian Labour Inspection Authority
- Responsible party
- Principal investigator, Jarle Jakobsen, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896178
- Sponsor's protocol ID
- 2019/542
- Status last verified
- Feb 2021
- First submitted
- 28 Mar 2019
- Last updated
- 1 Mar 2021
- Results posted
- 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 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Prostate Cancer in Firefighters - a Register-based Study of Prognostic Factors and Survival
- ClinicalTrials.gov ID
- NCT03896178
- Acronym / sponsor ID
- 2019/542
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137,536 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Extrastiftelsen, National Institute for Occupational Safety and Health (NIOSH/CDC), Norwegian Confederation of Trade Unions, Fagforbundet, Gjensidige Foundation, Norwegian Cancer Society, Norwegian Firefighters Fight Cancer, Norwegian Labour Inspection Authority
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 29 Mar 2019 (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.
Firefighters, police, military personnel and pilots are all shown to have a higher incidence of prostate cancer than the general population. A possible explanation for this is that these four groups of employees need regular mandatory health-checkups. If these checkups increase the chances of having a PSA or DRE performed one could expect the workers in question to have a higher probability than the general population of being diagnosed with prostate cancer. If this is the case the four groups should have cancers that are lower grade and have better survival. The investigators wish to examine this by comparing the four groups with a control group made up of all other workers with regards to prognostic factors at the time of diagnosis and survival rates. This will be done by extracting data from the Cancer Registry of Norway, coupled with employment data from Statistics Norway. This study is also a part of a project on cancer in firefighters. If the prostate cancers in firefighters differ significantly from the other three specified groups, this could point to an exposure specific for firefighters, e.g. fire smoke, as an etiologic factor.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 60 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Firefighters | – | Other: None, observational study |
| Pilots | – | Other: None, observational study |
| Police | – | Other: None, observational study |
| Military personnel | – | Other: None, observational study |
| Controls | – | Other: None, observational studyControl group matched for geographic location (county), and year of diagnosis. Consisting of all other workers than the four specified groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men registered in the Cancer Registry of Norway with prostate cancer. Analysis of firefighters, pilots, police, military personnel and a matched group of other workers.
Key inclusion criteria (1 listed)
- All cases of prostate cancer as registered by the Cancer Registry of Norway
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| None, observational studyNone, observational study | Other | Controls, Firefighters, Military personnel, Pilots, Police |
Primary outcome
Cause-specific mortality rate for prostate cancer
Time frame: From January 1st 1960 until December 31st 2018
4 secondary outcomes
TNM staging
Time frame: January 1st 1960 until December 31st 2018
Gleason score
Time frame: January 1st 1960 until December 31st 2018
PSA at time of diagnosis
Time frame: January 1st 1960 until December 31st 2018
Functional status at time of diagnosis (WHO classification)
Time frame: January 1st 1960 until December 31st 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cause-specific mortality rate for prostate cancer (time frame: From January 1st 1960 until December 31st 2018). 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 1 Mar 2021.