Comparison of Two Dose Assessment Methods for Exposures to Nuclear Detonation Radiation

NCT02226874 | Completed

• 2 other identifiers: 99991417014-C-N170
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The National Cancer Institute was funded to study how much radiation U.S. veterans who served in the 1950s were exposed to. Researchers want to estimate how much radiation these veterans received. They will use two methods and compare them. One is to interview the veterans and study their military records. The other is to take blood samples and look for certain types of changes in the blood cells. Being exposed to some kinds of radiation is known to cause changes in blood cells. The amount of changes to these cells tells scientists about how much radiation was received. Objectives: \- To better understand how to measure how much radiation a person has received. Eligibility:

• Veterans who were exposed to radiation at a specific site in the Pacific in 1954 or other sites in the 1950s.
• Veterans close in age to the first group, who have low levels of exposure to radiation.
• Men about 25 years old with no exposure to radiation. Design:
• Participants will have 1 visit, in their home.
• All participants will have blood drawn. This will take 10 minutes.
• The exposed veterans will be interviewed. They will answer questions about the nuclear events they experienced. This will take up to 40 minutes.
• For the exposed veterans, researchers will look at their military records, if they can. They will estimate how much radiation the veteran received.

Conditions

Radiation Exposure

Keywords

Dose Estimation; Dose Reconstruction; Methods; Fallout; Radiation Exposure

Outcome Measures

Primary Outcomes (1)

• Dosimetry data

  Comparing dosimetry data between cases and controls

  September 2014 - December 2016

Eligibility Criteria

• Age: 80 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

* ELIGIBILITY CRITERIA: EXPOSED VETERANS. Subjects for this investigation are required to have received, according to military records, whole-body radiation doses in excess of 0.25 Sv to ensure adequate detection of the radiation exposure by the FISH method. The recorded doses are crude dose estimates, often based on group radiation monitoring rather than on individual data, however, they are the only information available, upon which to select the study subjects that meet our criteria. To date, 16 exposed veterans that meet this requirement have been identified by the AVES through accessing databases of the NTPRP constructed by the Dept. of Defense.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Related Publications (3)

• Edwards AA, Szluinska M, Lloyd DC. Reconstruction of doses from ionizing radiation using fluorescence in situ hybridization techniques. Br J Radiol. 2007 Sep;80 Spec No 1:S63-7. doi: 10.1259/bjr/24766640.

  PMID: 17704328 BACKGROUND

• Hande MP, Azizova TV, Geard CR, Burak LE, Mitchell CR, Khokhryakov VF, Vasilenko EK, Brenner DJ. Past exposure to densely ionizing radiation leaves a unique permanent signature in the genome. Am J Hum Genet. 2003 May;72(5):1162-70. doi: 10.1086/375041. Epub 2003 Apr 4.

  PMID: 12679897 BACKGROUND

• Sigurdson AJ, Ha M, Hauptmann M, Bhatti P, Sram RJ, Beskid O, Tawn EJ, Whitehouse CA, Lindholm C, Nakano M, Kodama Y, Nakamura N, Vorobtsova I, Oestreicher U, Stephan G, Yong LC, Bauchinger M, Schmid E, Chung HW, Darroudi F, Roy L, Voisin P, Barquinero JF, Livingston G, Blakey D, Hayata I, Zhang W, Wang C, Bennett LM, Littlefield LG, Edwards AA, Kleinerman RA, Tucker JD. International study of factors affecting human chromosome translocations. Mutat Res. 2008 Apr 30;652(2):112-21. doi: 10.1016/j.mrgentox.2008.01.005. Epub 2008 Feb 2.

  PMID: 18337160 BACKGROUND

Study Officials

• Steven L Simon

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: August 26, 2014
• Primary Completion: May 31, 2016
• Study Completion: May 31, 2016
• Last Updated: December 12, 2019

Record last verified: 2019-04-24

Locations

US (1)