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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03896178
Other study ID # 2019/542
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2020
Est. completion date February 2, 2020

Study information

Verified date February 2021
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 137536
Est. completion date February 2, 2020
Est. primary completion date February 2, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - All cases of prostate cancer as registered by the Cancer Registry of Norway Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
None, observational study
None, observational study

Locations

Country Name City State
Norway Cancer Registry of Norway Oslo

Sponsors (10)

Lead Sponsor Collaborator
Oslo University Hospital Cancer Registry of Norway, Extrastiftelsen, Fagforbundet, Gjensidige Foundation, Norwegian Cancer Society, Norwegian Confederation of Trade Unions, Norwegian Firefighters Fight Cancer, Norwegian Labour Inspection Authority, The National Institute of Occupational Health

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cause-specific mortality rate for prostate cancer From January 1st 1960 until December 31st 2018
Secondary TNM staging January 1st 1960 until December 31st 2018
Secondary 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). January 1st 1960 until December 31st 2018
Secondary PSA at time of diagnosis January 1st 1960 until December 31st 2018
Secondary Functional status at time of diagnosis (WHO classification) January 1st 1960 until December 31st 2018
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