Prostatic CancerNCT03893123
Prostate Cancer Risk in Firefighters
An observational study of Prostatic Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Firefighters have been shown to be at increased risk for various types of cancer, including prostate cancer. This study will try to explore possible reasons for this increase in risk. A study group at the Cancer Registry of Norway is creating a cohort of Norwegian firemen employed from 1960 onwards. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Cancer
- What is being tested?
- Observational study, prostate cancer is outcome of interest
- How many people
- 4,500 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to Dec 2021
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Norwegian males
Who may be able to join
- Work as firefighter as recorded by the participating fire stations
Who cannot join
- Any other occupation, including chimney sweepers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostate Cancer Risk in Firefighters: Its Association to Qualitative and Quantitative Indicators of Exposure
Firefighters have been shown to be at increased risk for various types of cancer, including prostate cancer. This study will try to explore possible reasons for this increase in risk. A study group at the Cancer Registry of Norway is creating a cohort of Norwegian firemen employed from 1960 onwards. A job exposure matrix (JEM) is also being constructed, examining different types of exposure to potentially cancer-inducing agents and activities, and how these have changed historically. Examples include exposure to fire-smoke, shiftwork, diesel exhaust and regular health check-ups. By linking the cohort with data from the Cancer Registry of Norway and the JEM the investigators can examine which exposure assessments, if any, are related to an increased risk of prostate cancer.
- Conditions
- Prostatic Cancer
- Being tested
- Observational study, prostate cancer is outcome of interest
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, prostate cancer is outcome of interestOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Firefighters | Not described Receives: Other: Observational study, prostate cancer is outcome of interest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of prostate cancer
As reported to the Cancer Registry of Norway
Measured: From 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 posted28 Mar 2019
- Study start1 Jan 2018
- Primary completion1 Feb 2020
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,500 participants (actual)
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
- NCT03893123
- Sponsor's protocol ID
- 2016/2282
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2019
- Last updated
- 4 Mar 2020
- 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 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Risk in Firefighters: Its Association to Qualitative and Quantitative Indicators of Exposure
- ClinicalTrials.gov ID
- NCT03893123
- Acronym / sponsor ID
- 2016/2282
- Conditions
- Prostatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 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 Jan 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 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 have been shown to be at increased risk for various types of cancer, including prostate cancer. This study will try to explore possible reasons for this increase in risk. A study group at the Cancer Registry of Norway is creating a cohort of Norwegian firemen employed from 1960 onwards. A job exposure matrix (JEM) is also being constructed, examining different types of exposure to potentially cancer-inducing agents and activities, and how these have changed historically. Examples include exposure to fire-smoke, shiftwork, diesel exhaust and regular health check-ups. By linking the cohort with data from the Cancer Registry of Norway and the JEM the investigators can examine which exposure assessments, if any, are related to an increased risk of prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firefighters | – | Other: Observational study, prostate cancer is outcome of interest |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Norwegian males
Key inclusion criteria (1 listed)
- Work as firefighter as recorded by the participating fire stations
Key exclusion criteria (1 listed)
- Any other occupation, including chimney sweepers
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 |
|---|---|---|
| Observational study, prostate cancer is outcome of interestObservational study | Other | Firefighters |
Primary outcome
Incidence of prostate cancer
Time frame: From January 1st 1960 until December 31st 2018
As reported to the Cancer Registry of Norway
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- 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 Prostatic 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: status not confirmed, as of the sponsor's last update on 4 Mar 2020. 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?
Results are not available in the source record.
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?
Incidence of 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 4 Mar 2020.