Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410475
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2006-12-12
Brief Title:
Cancer Risk in X-Ray Technologists Second Survey
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cancer Risk in X-Ray Technologists
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers at the National Cancer Institute and the University of Minnesota have followed a nationwide cohort of 146022 radiologic technologists since 1982 Boice 1992 Doody 1998 Mohan 2003 Sigurdson 2003 This is one of the largest cohorts of medical radiation workers studied to date Yoshinaga 2003and the only one with substantial numbers of women 73 female extensive covariate data both incident and death outcomes and estimated occupational radiation doses The overall study objectives are to quantify radiation dose-response for cancers of the breast thyroid and other radiogenic sites assess cancer risks associated with genotypic phenotypic or other biologically measurable factors and determine if genetic variation modifies radiation-related cancer risks
More than 110000 technologists completed at least one of three comprehensive questionnaire surveys administered over the last 20 years and 18500 are deceased The First Survey was mailed during 1984-1989 to 132454 known living radiologic technologists of whom 90305 68 completed the survey Boice 1992 The Second Survey was mailed during 1993-1998 to 126628 known living technologists of whom 90972 72 completed the questionnaire Sigurdson2003 Both surveys included detailed questions about employment as a radiologic technologist family history of cancer reproductive history height weight other cancer risk factors such as alcohol and tobacco use history of personal diagnostic and therapeutic medical radiation procedures and information on cancer and other health outcomes A third follow-up of this cohort was recently completed During 2003-2005 the Third Survey was mailed or administered by telephone to 101694 living cohort members who had completed at least one of the two previous surveys 73838 technologists 73 completed the survey This questionnaire elicited information on medical outcomes to assess radiation-related risks detailed calendar-specific employment data to refine the occupational ionizing radiation dose estimates and behavioral and residential histories for estimating lifetime ultraviolet UV radiation exposures
The large number of women with estimates of cumulative radiation dose to specific organs eg breast Simon 2006 see Figure 7 and Table 9 offers at are opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers the two most sensitive organ sites for radiation carcinogenesis in women We are not aware of any other study population in which both quantified radiation doses and biospecimens are available for individuals with protracted low-dose ionizing radiation exposures Incorporation of assessment of the role of genetic polymorphisms and molecular variants in DNA repair and other genetic pathways that may be functionally important in radiation carcinogenesis would provide initial results on the possible role of genetic factors in the cancer-radiation relationship Because large numbers of women are exposed to ubiquitous low-dose radiation from occupational medical and environmental sources the presence of radiation-sensitive genetic variants that influence the risk of breast and other cancers would have important public health implications
More than 110000 technologists completed at least one of three comprehensive questionnaire surveys administered over the last 20 years and 18500 are deceased The First Survey was mailed during 1984-1989 to 132454 known living radiologic technologists of whom 90305 68 completed the survey Boice 1992 The Second Survey was mailed during 1993-1998 to 126628 known living technologists of whom 90972 72 completed the questionnaire Sigurdson2003 Both surveys included detailed questions about employment as a radiologic technologist family history of cancer reproductive history height weight other cancer risk factors such as alcohol and tobacco use history of personal diagnostic and therapeutic medical radiation procedures and information on cancer and other health outcomes A third follow-up of this cohort was recently completed During 2003-2005 the Third Survey was mailed or administered by telephone to 101694 living cohort members who had completed at least one of the two previous surveys 73838 technologists 73 completed the survey This questionnaire elicited information on medical outcomes to assess radiation-related risks detailed calendar-specific employment data to refine the occupational ionizing radiation dose estimates and behavioral and residential histories for estimating lifetime ultraviolet UV radiation exposures
The large number of women with estimates of cumulative radiation dose to specific organs eg breast Simon 2006 see Figure 7 and Table 9 offers at are opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers the two most sensitive organ sites for radiation carcinogenesis in women We are not aware of any other study population in which both quantified radiation doses and biospecimens are available for individuals with protracted low-dose ionizing radiation exposures Incorporation of assessment of the role of genetic polymorphisms and molecular variants in DNA repair and other genetic pathways that may be functionally important in radiation carcinogenesis would provide initial results on the possible role of genetic factors in the cancer-radiation relationship Because large numbers of women are exposed to ubiquitous low-dose radiation from occupational medical and environmental sources the presence of radiation-sensitive genetic variants that influence the risk of breast and other cancers would have important public health implications
Detailed Description:
BACKGROUND
The Radiation Epidemiology Branch and the University of Minnesota have followed a nationwide cohort of 146022 US radiologic technologists USRT since 1982 to assess cancer and other disease risks associated with long-term repeated low doses of ionizing radiation The USRT Study is the largest cohort of medical radiation workers studied to date and the only one with substantial numbers of women extensive covariate data incident and fatal cancer and other outcomes estimates of individual historical occupational radiation doses personal medical radiation doses and personal and residential solar ultraviolet radiation UVR doses and biospecimens for breast and thyroid cancer cases and comparison subjects This cohort is uniquely suited for addressing outstanding scientific questions about differences in risk related to the nature of radiation exposure specifically whether risks are the same from a single or a few high-dose exposures eg atomic bomb radiotherapy or from many small exposures over time that might be mitigated by DNA repair or other mechanisms The nationwide distribution of the cohort with wide-ranging UVR exposures also offers a rare opportunity to evaluate risks for non-melanoma skin cancer with UVR which will be a major focus of study during the next few years
OBJECTIVES
1 Assess risks of cancer and other diseases from long-term low-dose occupational and personal medical exposures
2 Assess risks of cancer and other diseases from occupational exposure to emerging and evolving radiologic modalities ie nuclear medicine fluoroscopically-guided procedures
3 Assess risks of skin and other cancers from solar ultraviolet radiation exposures
4 Conduct discovery of genetic determinants for thyroid cancer and rapid replication of main genotype effects for breast cancer
5 Evaluate gene-radiation and ionizing radiation-ultraviolet radiation interactions
ELIGIBILITY
All radiologic technologists certified by the American Registry of Radiologic Technologists for at least two years during 1926-1982 were eligible for study Excluded were technologists who resided outside the US
DESIGN
Cohort study The full USRT cohort consists of 146022 radiologic technologists The cohort is predominantly female 73 Caucasian 93 and presently 67 years old on average 83 are living and 16 are deceased or presumed deceased Three questionnaire surveys were conducted during 1983-2005 to collect information on occupational personal medical and personal and ambient residential ultraviolet radiation exposures other cancer risk factors and cancer and other disease outcomes More than 110000 technologists participated in the first andor second surveys The most recent follow-up third survey was conducted during 2003-2005 to obtain detailed work history information for improving occupational dosimetry Enhanced estimates of individual annual badge dose personal dose equivalent and radiation absorbed doses to 12 organs and tissues breast thyroid brain red bone-marrow lung heart ovary colon testes skin of extremities skin of head and neck and lens of eye were recently completed for survey participants Linear dose-response analyses are underway to quantify risks from protracted low-dose radiation for cancers eg breast thyroid and other radiation-related diseases eg cardiovascular cataracts A fourth questionnaire survey is under development and will collect information on cancer and other disease outcomes work history with nuclear medicine and fluoroscopically-guided procedures and other risk factors Fourth survey outcomes will be used to assess incident cancer risks with UVR exposure data collected on the third survey Collection of blood or buccal cell samples from breast and thyroid cancer cases and comparison subjects continues Future plans include a case-control study of basal cell carcinoma to assess risks with ultraviolet and ionizing radiation exposure genetic variants and interactions
The Radiation Epidemiology Branch and the University of Minnesota have followed a nationwide cohort of 146022 US radiologic technologists USRT since 1982 to assess cancer and other disease risks associated with long-term repeated low doses of ionizing radiation The USRT Study is the largest cohort of medical radiation workers studied to date and the only one with substantial numbers of women extensive covariate data incident and fatal cancer and other outcomes estimates of individual historical occupational radiation doses personal medical radiation doses and personal and residential solar ultraviolet radiation UVR doses and biospecimens for breast and thyroid cancer cases and comparison subjects This cohort is uniquely suited for addressing outstanding scientific questions about differences in risk related to the nature of radiation exposure specifically whether risks are the same from a single or a few high-dose exposures eg atomic bomb radiotherapy or from many small exposures over time that might be mitigated by DNA repair or other mechanisms The nationwide distribution of the cohort with wide-ranging UVR exposures also offers a rare opportunity to evaluate risks for non-melanoma skin cancer with UVR which will be a major focus of study during the next few years
OBJECTIVES
1 Assess risks of cancer and other diseases from long-term low-dose occupational and personal medical exposures
2 Assess risks of cancer and other diseases from occupational exposure to emerging and evolving radiologic modalities ie nuclear medicine fluoroscopically-guided procedures
3 Assess risks of skin and other cancers from solar ultraviolet radiation exposures
4 Conduct discovery of genetic determinants for thyroid cancer and rapid replication of main genotype effects for breast cancer
5 Evaluate gene-radiation and ionizing radiation-ultraviolet radiation interactions
ELIGIBILITY
All radiologic technologists certified by the American Registry of Radiologic Technologists for at least two years during 1926-1982 were eligible for study Excluded were technologists who resided outside the US
DESIGN
Cohort study The full USRT cohort consists of 146022 radiologic technologists The cohort is predominantly female 73 Caucasian 93 and presently 67 years old on average 83 are living and 16 are deceased or presumed deceased Three questionnaire surveys were conducted during 1983-2005 to collect information on occupational personal medical and personal and ambient residential ultraviolet radiation exposures other cancer risk factors and cancer and other disease outcomes More than 110000 technologists participated in the first andor second surveys The most recent follow-up third survey was conducted during 2003-2005 to obtain detailed work history information for improving occupational dosimetry Enhanced estimates of individual annual badge dose personal dose equivalent and radiation absorbed doses to 12 organs and tissues breast thyroid brain red bone-marrow lung heart ovary colon testes skin of extremities skin of head and neck and lens of eye were recently completed for survey participants Linear dose-response analyses are underway to quantify risks from protracted low-dose radiation for cancers eg breast thyroid and other radiation-related diseases eg cardiovascular cataracts A fourth questionnaire survey is under development and will collect information on cancer and other disease outcomes work history with nuclear medicine and fluoroscopically-guided procedures and other risk factors Fourth survey outcomes will be used to assess incident cancer risks with UVR exposure data collected on the third survey Collection of blood or buccal cell samples from breast and thyroid cancer cases and comparison subjects continues Future plans include a case-control study of basal cell carcinoma to assess risks with ultraviolet and ionizing radiation exposure genetic variants and interactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH97-C-N053 | None | None | None |