- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05380570
Epidemiological Study of Korean Radiation Workers (KRWS)
Health Effects Associated With Occupational Radiation Exposure Among Korean Radiation Workers (Korean Radiation Workers Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study population of this study is approximately 190000 Korean radiation workers registered with the Nuclear Safety and Security Commission since 1984. Diagnostic medical radiation workers were not included in the study population. The national dose registry, the national cancer registry, the national vital statistics registry, and the national health insurance data for radiation workers are collected retrospectively or prospectively based on the Nuclear Safety Act. Through the linkage of those collected data, we will evaluate radiation-induced health risks including cancer and non-cancer diseases. This data collection will be continued at 5-year intervals to update information on existing study participants and recruit newly hired workers if possible.
Age- and sex-specific standardized incidence and mortality ratios will be calculated for overall comparisons of cancer and non-cancer disease risks with general population. For dose-response assessment, excess relative risk (per Gy) and excess absolute risk (per Gy) will be estimated with adjustments for age and potential confounders, such as lifestyle factors and socioeconomic status.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Songwon Seo, Ph.D.
- Phone Number: +82-2-3399-5891
- Email: seo@kirams.re.kr
Study Contact Backup
- Name: Dalnim Lee, Ph.D.
- Phone Number: +82-2-3399-5892
- Email: leemoon@kirams.re.kr
Study Locations
-
-
Nowon-gu
-
Seoul, Nowon-gu, Korea, Republic of, 01812
- Korea Institute of Radiological & Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Korean radiation workers in the national dose registry (except for diagnostic medical radiation workers)
Exclusion Criteria:
- Unidentified personal identification numbers
- Foreigner
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Korean radiation workers
The study population is Korean radiation workers exposed to ionizing radiation in workplaces.
Diagnostic medical radiation workers were not included in the study population.
|
Ionizing radiation in workplaces
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation-induced cancer risk
Time Frame: year 4
|
Cancer risk associated with occupational radiation exposure
|
year 4
|
Radiation-induced cancer risk
Time Frame: year 9
|
Cancer risk associated with occupational radiation exposure
|
year 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation-induced non-cancer risk
Time Frame: year 4
|
Non-cancer disease risk associated with occupational radiation exposure
|
year 4
|
Radiation-induced non-cancer risk
Time Frame: year 9
|
Non-cancer disease risk associated with occupational radiation exposure
|
year 9
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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