NCT02734303

Brief 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. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

April 6, 2016

Last Update Submit

March 3, 2021

Conditions

Keywords

Dietary RadioactivityDietary AssessmentRetrospective RecallFocus Group

Outcome Measures

Primary Outcomes (1)

  • risk assessment

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

    Cumulative since 1945 exposure

Study Arms (1)

Potentially Exposed NM Residents

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

Eligibility Criteria

Age70 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Hispanic/Latino, non-Hispanic White or Native American
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (2)

  • 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.

    PMID: 12003020BACKGROUND
  • 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.

    PMID: 24286002BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Steven L Simon, Ph.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 12, 2016

Study Start

March 17, 2016

Primary Completion

September 12, 2017

Study Completion

December 1, 2019

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations