Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-08 @ 5:17 AM
Study NCT ID:
NCT02734303
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'risk assessment', 'timeFrame': 'Cumulative since 1945 exposure', 'description': 'prediction of number of excess cancers of: colon, lung, active bone marrow, stomach, and thyroid'}]}, 'conditionsModule': {'keywords': ['Dietary Radioactivity', 'Dietary Assessment', 'Retrospective Recall', 'Focus Group'], 'conditions': ['Cancers']}, 'referencesModule': {'references': [{'pmid': '12003020', 'type': 'BACKGROUND', 'citation': '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': '24286002', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe 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.\n\nObjective:\n\nTo learn about the health risks for people who may have been exposed to radiation from the Trinity nuclear test.\n\nEligibility:\n\nPeople who:\n\n* Are Native American, Hispanic/Latino, or non-Hispanic white\n* Are age 70 and older\n* Lived near the fallout region of the Trinity test and know about lifestyle and dietary patterns in New Mexico in the 1940s and 1950s\n\nDesign:\n\nParticipants will be screened with a questionnaire.\n\nParticipants 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:\n\n* Questions about their and their family members activities and eating habits in the 1940s and 1950s\n* 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.\n* Filling out a chart of their family members and the foods they ate\n\nIf participants give permission, their interview or group session will be recorded.\n\n...', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of the state of New Mexico (NM) potentially exposed to radioactive fallout from the Trinity nuclear test conducted in 1945.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Hispanic/Latino, non-Hispanic White or Native American\n* 70 years or older (Alive in 1945)\n* Resided in New Mexico or on one of New Mexico s tribal reservations (if Native American) during the 1940s and 1950s\n* Ideally, helped to care for children in his or her community during the 1940s\n* Potential focus group members an d key informants may include any of the following:\n\n * Community elders, tribal members, and people with first hand knowledge of food practices in New Mexico in the 1940s or 1950s.\n * Individuals must self-identify as a New Mexico tribal community member, Hispanic/Latino or non-Hispanic white in order to participate\n\nin an interview, and have firsthand knowledge about lifestyle and dietary patterns in New Mexico during the 1940s or 1950s.'}, 'identificationModule': {'nctId': 'NCT02734303', 'briefTitle': 'Study to Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Study to Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test', 'orgStudyIdInfo': {'id': '999916083'}, 'secondaryIdInfos': [{'id': '16-C-N083'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Potentially Exposed NM Residents', 'description': 'residents of the state of New Mexico (NM) potentially exposed to radioactive fallout fromthe Trinity nuclear test conducted in 1945'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Steven L Simon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}