Epidemiological Study of Korean Radiation Workers

Occupational Exposure to Radiation Clinical Trial

— KRWS  

Official title:

Health Effects Associated With Occupational Radiation Exposure Among Korean Radiation Workers (Korean Radiation Workers Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05380570
• Other study ID #: 50091
• Status: Active, not recruiting
• Start date: November 18, 2021
• Est. completion date: March 31, 2031

Study information

• Verified date: April 2023
• Source: Korea Institute of Radiological & Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Health risks of radiation exposure in the moderate-to-high dose range have been well established. However, the risk remains unclear at low-dose ranges with protracted low-dose rate exposure, which is typical of occupational exposure. The purpose of this study is to construct a cohort of Korean radiation workers and to assess health effects associated with occupational radiation exposure. The study population is expected to be about 190,000 Korean radiation workers who have been registered with the Nuclear Safety and Security Commission since 1984. The national dose registry, the national cancer registry, the national vital statistics registry, and the national health insurance data are collected 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196379
• Est. completion date: March 31, 2031
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Korean radiation workers in the national dose registry (except for diagnostic medical radiation workers)

Exclusion Criteria:

• Unidentified personal identification numbers

• Foreigner

Related Conditions & MeSH terms

• Occupational Exposure to Radiation
• Radiation Effects

Intervention

Radiation:
• Occupational radiation exposure
Ionizing radiation in workplaces

Locations

Country	Name	City	State
Korea, Republic of	Korea Institute of Radiological & Medical Sciences	Seoul	Nowon-gu

Sponsors (1)

Lead Sponsor	Collaborator
Korea Institute of Radiological & Medical Sciences

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Seo S, Lim WY, Lee DN, Kim JU, Cha ES, Bang YJ, Lee WJ, Park S, Jin YW. Assessing the health effects associated with occupational radiation exposure in Korean radiation workers: protocol for a prospective cohort study. BMJ Open. 2018 Mar 30;8(3):e017359. doi: 10.1136/bmjopen-2017-017359. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation-induced cancer risk	Cancer risk associated with occupational radiation exposure	year 4
Primary	Radiation-induced cancer risk	Cancer risk associated with occupational radiation exposure	year 9
Secondary	Radiation-induced non-cancer risk	Non-cancer disease risk associated with occupational radiation exposure	year 4
Secondary	Radiation-induced non-cancer risk	Non-cancer disease risk associated with occupational radiation exposure	year 9