OVERVIEW

The National Health Service (NHS) routinely offers breast screening every 3 years to all UK women aged 50-70. In 2012, an independent panel concluded that, while routine breast screening at ages 50-70 confers significant benefit to UK women, the advantages and disadvantages of starting breast screening at younger or older ages were uncertain (read report).

The AgeX trial will assess reliably the risks and benefits of offering an extra screen to women aged 47-49 (who will all be offered routine screening anyway three years later) and, separately, of offering additional screening to women after age 70 (who will already have been offered routine screening every 3 years at ages 50-70). Click here for a copy of the AgeX Trial protocol.

The trial is taking place in most breast screening centres in England. Screening records of participants are being linked electronically with routinely collected government records to help assess the short-term and long-term effects of the additional screening.

The trial will involve about five-sixths of the 80 NHS breast screening centres in England (participating centres). The screening centres in England that are not participating are mainly those that use non-standard methods to invite women for screening.

In the participating screening centres groups of women (clusters) are allocated at random, like tossing a coin, either for the whole group to be invited for screening, or for the whole group not to be invited. A typical cluster might involve a few dozen or a few hundred women who live near each other aged 47-49 or aged 71-73. All women in each cluster who are randomly allocated not to be invited, also join the trial as controls. For each separate age range the study will compare, over the next decade or so, what happens to women in the clusters invited for screening and in the clusters not invited.

This trial is embedded within the routines of the NHS breast screening programme in England, which currently uses two-view digital mammography. Other than randomisation, all aspects of screening will be conducted exactly as normal in the breast screening programme, following its routine procedures.

FREQUENTLY ASKED QUESTIONS

How do I know if women living in my area are being recruited into the trial?
A poster will be displayed in GPs’ surgeries when the screening teams are working in the area where you live (Trial poster). Women invited for screening will be sent the trial participant information sheet (Information sheet).

Can I be screened if I am not invited?
Women aged 47-49 who are not invited or initially decline this invitation but then change their mind can still ask to be screened if they live in an area participating in the trial. Women aged over 70, irrespective of the trial, are already able to request screening every three years.

How long will the trial continue?
The trial will continue until reliable evidence emerges about the benefits and risks of screening in each age group, which is likely to be at least until the mid-2020s.

Who is organising the trial and who is paying for it?
A team at the University of Oxford serves as the co-ordinating centre for the trial and is responsible for assessing the effects of extending the age range for breast screening (further details).

Funds from the Department of Health are allocated to Public Health England for the screening of women in the trial. Data analysis is funded from the quinquennial core support for the Cancer Epidemiology Unit and for the Clinical Trial Service Unit (both in the University of Oxford’s Nuffield Department of Population Health), from the Medical Research Council and from Cancer Research UK.

How will information about trial participants be used?
The national breast screening database provides the investigators with information on trial entrants that includes patient identifiers needed for electronic record linkage to routinely collected NHS data held by NHS Digital and by Public Health England.

NHS Digital holds routinely collected NHS health records for England, including hospital admission data, cancer registrations, and death records, some of which are supplied by the Office for National Statistics (ONS), sourced from civil registration data. NHS Digital is able to provide the study team with electronically linked information about these outcomes for individual women in all clusters whether or not they were invited for screening. To do this, identifiable data including name, NHS Number and date of birth is supplied by the study investigators to NHS Digital. Linkage to patient-identifiable data without consent and for access to medical records by those outside the healthcare team, has been approved under Section 251 of the NHS Act 2006.

Public Health England provides investigators with information about screening history and further details about cancers.

The linked data provided to the study team are stored securely in accordance with the Data Protection Act and procedures and policies of the University of Oxford. Once linked, however, all these records will be made anonymous so the researchers using them will not be able to identify any individual.

No direct contact with study participants will be made by the research team, and the statistical analyses and reports will be of anonymised data.

The data will be held only at the University of Oxford. No data is released or shared in any form that would enable individual participants to be identified.

Participants can request more information about how their data are being used by writing to the address given below.

Can I opt out if I do not wish to be part of the trial?
If you wish to opt out of the trial please write, giving the single word “OPT-OUT” and your name, address and date of birth to: AgeX Trial Co-ordinating Centre; CEU, Richard Doll Building, Roosevelt Drive, Oxford OX3 7LF. This will in no way affect your screening or any treatment you receive.

This opt-out is part of confidential records relating to your current General Practice. If you move to a new General Practice then you may get re-invited as no record of your confidential opt-out request can be transferred.

What are the details of approvals that have been obtained for the trial?
Ethical approval for the trial was obtained in 2010 and again in 2014 was from Ealing & West London (now Harrow) Research Ethics Committee (ref: 10/H0710/9).

Section 251 support for the trial has been approved by the National Information Governance Board Ethics & Confidentiality Committee (ref: ECC 1-04 (b)/2010).

The trial is registered under the Data Protection Act (registration number Z575783X). The data security processes are approved under the NHS Information Governance Toolkit; our Information Governance and Information Security Policies (available here).

What are the details of trial registrations?
Trial registrations and links to them are:
ISRCTN33292440: click here
NCT01081288: click here.