- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03896178
Prostate Cancer in Firemen: Early Diagnosis Because of Increased Diagnostic Pressure?
February 24, 2021 updated by: Jarle Jakobsen, Oslo University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
137536
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0304
- Cancer Registry of Norway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- All cases of prostate cancer as registered by the Cancer Registry of Norway
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Firefighters
|
None, observational study
|
|
Pilots
|
None, observational study
|
|
Police
|
None, observational study
|
|
Military personnel
|
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.
|
None, observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cause-specific mortality rate for prostate cancer
Time Frame: From January 1st 1960 until December 31st 2018
|
From January 1st 1960 until December 31st 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TNM staging
Time Frame: January 1st 1960 until December 31st 2018
|
January 1st 1960 until December 31st 2018
|
|
|
Gleason score
Time Frame: January 1st 1960 until December 31st 2018
|
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).
|
January 1st 1960 until December 31st 2018
|
|
PSA at time of diagnosis
Time Frame: January 1st 1960 until December 31st 2018
|
January 1st 1960 until December 31st 2018
|
|
|
Functional status at time of diagnosis (WHO classification)
Time Frame: January 1st 1960 until December 31st 2018
|
January 1st 1960 until December 31st 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Actual)
February 2, 2020
Study Completion (Actual)
February 2, 2020
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
March 28, 2019
First Posted (Actual)
March 29, 2019
Study Record Updates
Last Update Posted (Actual)
March 1, 2021
Last Update Submitted That Met QC Criteria
February 24, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/542
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.