Radiation-Induced NeoplasmsNCT00410475
Cancer Risk in X-Ray Technologists: Second Survey
An observational study of Radiation-Induced Neoplasms and Breast+Neoplasm+Radiation+Etiology, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Researchers at the National Cancer Institute and the University of Minnesota have followed a nationwide cohort of 146,022 radiologic technologists since 1982 (Boice 1992; Doody 1998; Mohan 2003; Sigurdson 2003). Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Radiation-Induced Neoplasms, Breast+Neoplasm+Radiation+Etiology, Thyroid+Neoplasm+Radiation+Etiology
- How many people
- 146,022 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 1997to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible radiologic technologists certified by ARRT
Who may be able to join
- Medical x-ray technologists certified (at least two years during 1926-1982) by the American Registry of Radiologic Technicians (ARRT).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55415
About this study
Official title: Cancer Risk in X-Ray Technologists
Researchers at the National Cancer Institute and the University of Minnesota have followed a nationwide cohort of 146,022 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 2003)and 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 110,000 technologists completed at least one of three comprehensive questionnaire surveys administered over the last 20 years and 18,500 are deceased. The First Survey was mailed during 1984-1989 to 132,454 known living radiologic technologists, of whom 90,305 (68%) completed the survey (Boice 1992). The Second Survey was mailed during 1993-1998 to 126,628 known living technologists, of whom 90,972 (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 101,694 living cohort members who had completed at least one of the two previous surveys; 73,838 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 (e.g. 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.
Read the detailed description
BACKGROUND:
The Radiation Epidemiology Branch and the University of Minnesota have followed a nationwide cohort of 146,022 U.S. 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 (e.g. 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:
- Assess risks of cancer and other diseases from long-term low-dose occupational and personal medical exposures.
- Assess risks of cancer and other diseases from occupational exposure to emerging and evolving radiologic modalities (i.e. nuclear medicine, fluoroscopically-guided procedures).
- Assess risks of skin and other cancers from solar ultraviolet radiation exposures.
- Conduct discovery of genetic determinants for thyroid cancer and rapid replication of main genotype effects for breast cancer.
- 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 U.S.
DESIGN:
Cohort study: The full USRT cohort consists of 146,022 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 110,000 technologists participated in the first and/or 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 (e.g., breast, thyroid) and other radiation-related diseases (e.g., 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.
- Conditions
- Radiation-Induced Neoplasms, Breast+Neoplasm+Radiation+Etiology, Thyroid+Neoplasm+Radiation+Etiology
- Keywords
- Ionizing Radiation, Cohort Study, Radiation-Induced Neoplasms, Radiologic Technologists, Ultraviolet Radiation
- Medical subject headings
- Neoplasms, Radiation-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| U.S. radiologic technologists | Radiologic technologists certified by the American Registry of Radiologic Technologists (ARRT) during 1923-1980 and residing in any U.S. state or territory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ionizing radiation
Occupational ionizing radiation-related risks for cancer and other medical outcomes.
Measured: Work history information collected on questionnaires plus badge dose measurements
Secondary outcomes (1)
Ultraviolet radiation
Cancer and other disease risks associated with ultraviolet radiation exposure.
Measured: Sun exposure information and medical outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study start17 Sep 1997
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radiation-Induced NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Cari M Kitahara, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410475
- Sponsor's protocol ID
- 999997053
- Other IDs
- OH97-C-N053
- Status last verified
- Apr 2020
- First submitted
- 12 Dec 2006
- Last updated
- 7 Apr 2020
- Results posted
- No
Publications
Simon SL, Preston DL, Linet MS, Miller JS, Sigurdson AJ, Alexander BH, Kwon D, Yoder RC, Bhatti P, Little MP, Rajaraman P, Melo D, Drozdovitch V, Weinstock RM, Doody MM. Radiation organ doses received in a nationwide cohort of U.S. radiologic technologists: methods and findings. Radiat Res. 2014 Nov;182(5):507-28. doi: 10.1667/RR13542.1. Epub 2014 Oct 31.
PubMed 25361400Preston DL, Kitahara CM, Freedman DM, Sigurdson AJ, Simon SL, Little MP, Cahoon EK, Rajaraman P, Miller JS, Alexander BH, Doody MM, Linet MS. Breast cancer risk and protracted low-to-moderate dose occupational radiation exposure in the US Radiologic Technologists Cohort, 1983-2008. Br J Cancer. 2016 Oct 25;115(9):1105-1112. doi: 10.1038/bjc.2016.292. Epub 2016 Sep 13.
PubMed 27623235Kitahara CM, Preston DL, Neta G, Little MP, Doody MM, Simon SL, Sigurdson AJ, Alexander BH, Linet MS. Occupational radiation exposure and thyroid cancer incidence in a cohort of U.S. radiologic technologists, 1983-2013. Int J Cancer. 2018 Nov 1;143(9):2145-2149. doi: 10.1002/ijc.31270. Epub 2018 Feb 2.
PubMed 29355960
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Risk in X-Ray Technologists
- ClinicalTrials.gov ID
- NCT00410475
- Acronym / sponsor ID
- 999997053
- Conditions
- Radiation-Induced Neoplasms, Breast+Neoplasm+Radiation+Etiology, Thyroid+Neoplasm+Radiation+Etiology
- Keywords
- Ionizing Radiation, Cohort Study, Radiation-Induced Neoplasms, Radiologic Technologists, Ultraviolet Radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146,022 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Sep 1997 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers at the National Cancer Institute and the University of Minnesota have followed a nationwide cohort of 146,022 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 2003)and 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 110,000 technologists completed at least one of three comprehensive questionnaire surveys administered over the last 20 years and 18,500 are deceased. The First Survey was mailed during 1984-1989 to 132,454 known living radiologic technologists, of whom 90,305 (68%) completed the survey (Boice 1992). The Second Survey was mailed during 1993-1998 to 126,628 known living technologists, of whom 90,972 (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 101,694 living cohort members who had completed at least one of the two previous surveys; 73,838 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 (e.g. 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 146,022 U.S. 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 (e.g. 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:
- Assess risks of cancer and other diseases from long-term low-dose occupational and personal medical exposures.
- Assess risks of cancer and other diseases from occupational exposure to emerging and evolving radiologic modalities (i.e. nuclear medicine, fluoroscopically-guided procedures).
- Assess risks of skin and other cancers from solar ultraviolet radiation exposures.
- Conduct discovery of genetic determinants for thyroid cancer and rapid replication of main genotype effects for breast cancer.
- 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 U.S.
DESIGN:
Cohort study: The full USRT cohort consists of 146,022 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 110,000 technologists participated in the first and/or 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 (e.g., breast, thyroid) and other radiation-related diseases (e.g., 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U.S. radiologic technologists | – | –Radiologic technologists certified by the American Registry of Radiologic Technologists (ARRT) during 1923-1980 and residing in any U.S. state or territory. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible radiologic technologists certified by ARRT
Key inclusion criteria (1 listed)
- Medical x-ray technologists certified (at least two years during 1926-1982) by the American Registry of Radiologic Technicians (ARRT).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ionizing radiation
Time frame: Work history information collected on questionnaires plus badge dose measurements
Occupational ionizing radiation-related risks for cancer and other medical outcomes.
1 secondary outcome
Ultraviolet radiation
Time frame: Sun exposure information and medical outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 25361400Simon SL, Preston DL, Linet MS, Miller JS, Sigurdson AJ, Alexander BH, Kwon D, Yoder RC, Bhatti P, Little MP, Rajaraman P, Melo D, Drozdovitch V, Weinstock RM, Doody MM. Radiation organ doses received in a nationwide cohort of U.S. radiologic technologists: methods and findings. Radiat Res. 2014 Nov;182(5):507-28. doi: 10.1667/RR13542.1. Epub 2014 Oct 31.
- Background: PubMed 27623235Preston DL, Kitahara CM, Freedman DM, Sigurdson AJ, Simon SL, Little MP, Cahoon EK, Rajaraman P, Miller JS, Alexander BH, Doody MM, Linet MS. Breast cancer risk and protracted low-to-moderate dose occupational radiation exposure in the US Radiologic Technologists Cohort, 1983-2008. Br J Cancer. 2016 Oct 25;115(9):1105-1112. doi: 10.1038/bjc.2016.292. Epub 2016 Sep 13.
- Background: PubMed 29355960Kitahara CM, Preston DL, Neta G, Little MP, Doody MM, Simon SL, Sigurdson AJ, Alexander BH, Linet MS. Occupational radiation exposure and thyroid cancer incidence in a cohort of U.S. radiologic technologists, 1983-2013. Int J Cancer. 2018 Nov 1;143(9):2145-2149. doi: 10.1002/ijc.31270. Epub 2018 Feb 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cari M Kitahara principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation-Induced Neoplasms and Breast+Neoplasm+Radiation+Etiology, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ionizing radiation (time frame: Work history information collected on questionnaires plus badge dose measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00410475, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020; AzTrials last refreshed its copy on 31 Oct 2026.