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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05380570
Other study ID # 50091
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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