Condition category
Not Applicable
Date applied
24/01/2017
Date assigned
06/04/2017
Last edited
06/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The British Government undertook a series of atmospheric nuclear weapons tests at various sites in Australia and the South Pacific between 1952 and 1958. Associated with these tests was an experimental programme in which radioactivity was dispersed into the environment, this programme ended in 1963 although operations continued through to 1967. Additionally, UK personnel participated in a series of American tests based at Christmas Island in 1962. It is estimated that over 20,000 UK servicemen participated in at least one of these British and American tests.

An ongoing concern within the nuclear test community has been whether veterans of these programmes could have received sufficient radiation exposure to cause genetic damage (changes to the DNA) in them. Genetic damage can increase the risk of developing various diseases. This concern extends to whether they might also have passed on genetic alterations to their children, thereby potentially affecting their family’s health.

The aim of this study is to determine whether there is any evidence of genetic alteration in veterans of historical nuclear test sites and/or their children when compared to control family groups.

Who can participate?
1. UK veterans who participated in nuclear testing programmes, their wives/partners and their children
2. UK veterans who did not participate in nuclear testing programmes but did serve in a tropical location, their wives/partners and their children

What does the study involve?
UK veterans are identified using military records and they and their wives/partners are invited to take part through receiving a letter from their GP practice. Interested veteran couples reply to the letter and receive a phone call to discuss the study and their eligibility. Participants are allocated to either the test group or the control group based on their military service and their participation in the nuclear testing programme. Veteran couples are then asked to give consent and to pass on an invitation letter and further information about the study to a child they have had together. Veterans complete a brief telephone interview with the study team to discuss the details of their service, exposures to various things and a brief outline of their smoking and drinking habits. All participants (veteran, wife/partner and child) then go to their GP practice to have a small blood sample collected through placing a needle in a vein in their arm. The blood sample is sent for analysis. With each participant’s explicit consent, the study team monitor all written and electronic medical records to assess their lifelong health. This information is obtained automatically by linking participant NHS number to various medical records, including those held by NHS Digital on cancer registrations and deaths and the Hospital Episodes Statistics database on hospital admissions.

What are the possible benefits and risks of participating?
Participants may benefit from clarifying the uncertainty about the possible heath impact of participating in the nuclear testing programme in the past. Participants may experience discomfort during the collection of the blood sample.

Where is the study run from?
This study is run from the London School of Hygiene & Tropical Medicine (UK), Brunel University London (UK) and takes place in GP practices across the United Kingdom.

When is the study starting and how long is it expected to run for?
June 2016 to May 2019

Who is funding the study?
Armed Forces Covenant Aged Veterans Fund (UK)

Who is the main contact?
Dr Rhona Anderson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rhona Anderson

ORCID ID

http://orcid.org/0000-0003-2258-656X

Contact details

Division of Biosciences
Brunel university London
Uxbridge
UB8 3PH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v1

Study information

Scientific title

Cytogenetic assessment of British nuclear test veterans and their families

Acronym

Study hypothesis

To address whether there is a genetic legacy of participation at nuclear test sites the hypothesis are:
1. The frequency of chromosome aberrations detected in peripheral blood lymphocytes of a population of nuclear test veterans is significantly greater than that detected in a matched population
2. The spectra of chromosome aberrations detected in peripheral blood lymphocytes of a population of nuclear test veterans are significantly different from those in a matched population
3. The frequency of chromosome aberrations detected in peripheral blood lymphocytes of a population of 1st generation children is significantly greater than that detected in a matched population
4. The spectra of chromosome aberrations detected in peripheral blood lymphocytes of a population of 1st generation children are significantly different from those detected in a matched population

Ethics approval

London - Chelsea Research Ethics Committee, 24/02/2017, ref: 17/LO/0273

Study design

Observational case control study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Not applicable

Intervention

Participants (both case and control groups) are identified using military records and are invited to participate through receiving a letter from their doctor’s office.

If veterans and their wives/partners agree to participate they receive a telephone call to screen for interest and eligibility. The status of being allocated to the case group or the control group is confirmed during the telephone interview and is based on the participation in the nuclear testing programme and their service history. After giving informed consent they are asked to pass on the information sheet and consent form and study invitation to their offspring. Military veterans complete a short telephone call to collect details of their service and other potential clastogenic exposures. Participants give 17.5mL of blood, taken at their GP office, who then sends the blood to the Brunel University London laboratory. Using the fluorescence in situ hybridisation (FISH) based analysis, evidence of altered frequencies of chromosomal aberrations in veterans and/or in their children are compared to 50 control family groups. The study duration is three years.

All participants are flagged for lifelong follow-up through national registers for death and cancer registration and hospital admissions via Hospital Episode Statistics.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Cytogenetic evidence of differences in the frequency and spectra of chromosome aberrations in male nuclear test veterans and/or their children is assessed using a range of chromosomal assays by taking a blood sample.

Secondary outcome measures

1. Future genetic and cytogenetic assessments of familiy groups will be assessed using stored DNA and isolated blood cells from blood samples
2. Long-term health status is followed up through national registers for death and cancer registration and hospital admissions via Hospital Episode Statistics

Overall trial start date

01/06/2016

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Intervention group:
1. UK residents
2. Registered with a UK GP
3. Contactable by phone
4. Must be a veteran born in 1930 or later who participated in the nuclear testing programme
4.1. Be the wife or partner of the veteran and be registered at the same GP as the veteran
4.2. Veterans and participating partner must have a surviving child together who is resident and willing to take part in the study

Control group:
1. UK residents
2. Registered with a UK GP
3. Contactable by phone
4. Must be a veteran born in 1930 or later who did not serve in the nuclear testing programme but did serve in a tropical location
4.1. Be the wife or partner of the veteran and be registered at the same GP as the veteran
4.2. Veterans and participating partner must have a surviving child together who is resident and willing to take part in the study

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

50 family trios for test and control groups

Participant exclusion criteria

Veterans and participating children:
1. Been diagnosed with cancer (other than non-melanoma skin cancer)
2. Have had cytotoxic chemotherapy or radiation treatment for any reason (such as methotrexate for rheumatoid arthritis)

All participants:
1. Compromises the participant safety or compliance as judged by a GP

Recruitment start date

01/04/2017

Recruitment end date

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London School of Hygiene and Tropical Medicine
Keppel St
London
WC1E 7HT
United Kingdom

Trial participating centre

Brunel University London
Kingston Lane Uxbridge
London
UB8 3PH
United Kingdom

Sponsor information

Organisation

Brunel University London

Sponsor details

Kingston Lane
Uxbridge
UB8 3PH
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Not defined

Funder name

Armed Forces Covenant Aged Veterans Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

On completion of the study report, the main findings will be summarised and sent in a letter to those who participated in the study. Participants will also be able to access planned peer-reviewed publications in high-impact Journals reporting the results of the study. The study will be presented at nuclear community events and articles pertaining to the study results will be published in nuclear community publications.

IPD Sharing plan:
The current data sharing plans for the current study are not expected to be made available.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes