- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02734303
Study to Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test
Background:
The first nuclear bomb test took place in New Mexico in July 1945. This was called the Trinity test. Researchers want to learn how it affected the health of people who lived in New Mexico at the time of the test. To do this, they want to learn about the diet and daily life of those people at that time. They want to study Native Americans, Hispanic/Latinos, and non-Hispanic/Latino whites.
Objective:
To learn about the health risks for people who may have been exposed to radiation from the Trinity nuclear test.
Eligibility:
People who:
- Are Native American, Hispanic/Latino, or non-Hispanic white
- Are age 70 and older
- Lived near the fallout region of the Trinity test and know about lifestyle and dietary patterns in New Mexico in the 1940s and 1950s
Design:
Participants will be screened with a questionnaire.
Participants will answer questions in an interview or a focus group. This will be at a place like an office, tribal or community center, or library. It will take up to 2 hours. The interview or group session will include:
- Questions about their and their family members activities and eating habits in the 1940s and 1950s
- A card-sorting exercise: There will be cards with pictures and names of certain foods. They will sort the cards into 2 piles: those that were consumed and those that were not.
- Filling out a chart of their family members and the foods they ate
If participants give permission, their interview or group session will be recorded.
...
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- Hispanic/Latino, non-Hispanic White or Native American
- 70 years or older (Alive in 1945)
- Resided in New Mexico or on one of New Mexico s tribal reservations (if Native American) during the 1940s and 1950s
- Ideally, helped to care for children in his or her community during the 1940s
Potential focus group members an d key informants may include any of the following:
- Community elders, tribal members, and people with first hand knowledge of food practices in New Mexico in the 1940s or 1950s.
- Individuals must self-identify as a New Mexico tribal community member, Hispanic/Latino or non-Hispanic white in order to participate
in an interview, and have firsthand knowledge about lifestyle and dietary patterns in New Mexico during the 1940s or 1950s.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Potentially Exposed NM Residents
residents of the state of New Mexico (NM) potentially exposed to radioactive fallout fromthe Trinity nuclear test conducted in 1945
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
risk assessment
Time Frame: Cumulative since 1945 exposure
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prediction of number of excess cancers of: colon, lung, active bone marrow, stomach, and thyroid
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Cumulative since 1945 exposure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven L Simon, Ph.D., National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Simon SL, Bouville A. Radiation doses to local populations near nuclear weapons test sites worldwide. Health Phys. 2002 May;82(5):706-25. doi: 10.1097/00004032-200205000-00016.
- Schwerin M, Schonfeld S, Drozdovitch V, Akimzhanov K, Aldyngurov D, Bouville A, Land C, Luckyanov N, Mabuchi K, Semenova Y, Simon S, Tokaeva A, Zhumadilov Z, Potischman N. The utility of focus group interviews to capture dietary consumption data in the distant past: dairy consumption in Kazakhstan villages 50 years ago. J Dev Orig Health Dis. 2010 Jun;1(3):192-202. doi: 10.1017/S2040174410000243.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 999916083
- 16-C-N083
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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