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CompletedNCT02734303Updated Mar 4, 2021

Study to Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test

An observational study in Cancers, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 70 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-03-04.

Sponsored by National Cancer Institute (NCI) · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
90
Ages
70 Years to 100 Years
Sex
All
01

Study summary

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.

...

Read the detailed description

Over the last four decades, assessments of health risks based on estimated radiation doses received by the public have been completed for all major U.S. nuclear testing sites and nuclear fuel cycle facilities in the U.S. except for the Trinity test. This research plan is for a radiationrelated cancer risk projection study for the residents of the state of New Mexico (NM) potentially exposed to radioactive fallout from the Trinity nuclear test conducted in 1945. Data to be collected on diet and lifestyle from the three main ethnic groups in NM (white, Hispanic, and Native American) via focus groups and key informant interviews will be used to derive means and ranges of exposure-related parameters for a dose assessment and risk projection. As preliminary work to this proposal, in 2014 we conducted a pilot study to obtain information from 9 key informants (maximum number allowed under OMB regulations prior to clearance) determined that the elders could recall the relevant time period and relevant lifestyle practices. This work established that it is possible to: 1) locate elderly representative of the ethnic groups, 2) assemble groups of members of tribal, a n d Hispanic/Latino communities in New Mexico who were alive in 1945 at the time of the test to participate in focus groups, and 3) obtain lifestyle and diet information to be used for refining focus group interviewing tools. Due to the successful completion of the pilot phase, here we are proposing a second phase to collect data, on a larger scale, via focus group and individual interviews, on lifestyle and diet from up to 150 Native American, Hispanic/Latino, and non-Hispanic white participants living in New Mexico who were alive at the time of the Trinity detonation (currently greater than or equal to 70 years old). The data collected in the proposed study will allows us to estimate exposure-related parameter values that can be used in fallout dose assessment models to estimate external and internal radiation doses to representative persons in all counties in New Mexico by ethnicity, gender, and age. Those doses will be used with published risk models and coupled with literature-derived parameters on risk/unit dose to project the excess cancers (per 1,000 persons within each strata) expected. Endpoints are leukemia, thyroid cancer, stomach cancer, and colon cancer.

02

Conditions studied

  • Cancers

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Keywords

  • Dietary Radioactivity
  • Dietary Assessment
  • Retrospective Recall
  • Focus Group
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 90 is below the median of 202 across 1,742 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,554 studies on the registry; 334 are open to participants now.

Of its 407 completed or terminated interventional studies of FDA-regulated products, 370 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Residents of the state of New Mexico (NM) potentially exposed to radioactive fallout from the Trinity nuclear test conducted in 1945.

Eligibility criteria

  • 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.

05

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
90 participants (actual)

Groups and cohorts

  • Potentially Exposed NM Residents

    residents of the state of New Mexico (NM) potentially exposed to radioactive fallout fromthe Trinity nuclear test conducted in 1945

06

What researchers measure

Primary outcomes

  1. risk assessment

    prediction of number of excess cancers of: colon, lung, active bone marrow, stomach, and thyroid

    Time frame: Cumulative since 1945 exposure

07

Study locations

1 site
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
08

References and documents

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. PubMed 12003020 ↗
  • 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. PubMed 24286002 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2016 to primary completion in Sep 2017, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2016
First posted
Apr 12, 2016
StartActual
Mar 17, 2016
Primary completionActual
Sep 12, 2017
CompletionActual
Dec 1, 2019
Last update
Mar 4, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02734303
Responsible party
Sponsor
First posted
Apr 12, 2016
Start date
Mar 17, 2016
Primary completion
Sep 12, 2017
Completion
Dec 1, 2019
Last update
Mar 4, 2021

Study contacts

Steven L Simon, Ph.D.
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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