Prostate Cancer Risk in Firefighters | NCT03893123

Studies
Prostate Cancer Risk in Firefighters

NCT03893123

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Mar 4, 2020Actual

Enrollment

4,500Actual

Phase

Not provided

Conditions

Prostatic Cancer

Interventions

Observational study, prostate cancer is outcome of interest

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Feb 1, 2020Actual

Completion Date

Dec 2021Estimated

First Submitted Date

Mar 25, 2019

First Submission Date that Met QC Criteria

Mar 26, 2019

First Posted Date

Mar 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2020

Last Update Posted Date

Mar 4, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jarle Jakobsen, PhD-student, Norwegian Institute of Public HealthPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
Norwegian Institute of Public Health	OTHER_GOV
Extrastiftelsen	OTHER
National Institute for Occupational Safety and Health (NIOSH/CDC)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Firefighters			Other: Observational study, prostate cancer is outcome of interest

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational study, prostate cancer is outcome of interest	Other	Observational study	Firefighters

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of prostate cancer	As reported to the Cancer Registry of Norway	From January 1st 1960 until December 31st 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Work as firefighter as recorded by the participating fire stations

Exclusion Criteria:

Any other occupation, including chimney sweepers

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Norwegian males

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Registry of Norway		Oslo		0304	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided