Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01081288 |
| Other study ID # |
10/H0710/9 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2009 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
January 2023 |
| Source |
University of Oxford |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Nationwide cluster-randomised trial of extending the NHS breast screening age range in
England
Description:
In 1988, the national Breast Screening Programme (BSP) began offering women aged 50-64 years
triennial mammographic screening and full national coverage was achieved by the mid-1990s.
In 2003, the age range for triennial screening was extended from 50-64 to 50-70 years;
proposals from committees in the Department of Health to randomise this age extension and
thereby to obtain reliable information on both the risks and benefits of additional screening
at ages 65-70 were not adopted.
Currently, 80 breast screening units cover all of England, each responsible for a defined
area, and each year they invite about 2.8 million women aged 50-70, with 2.0 million
accepting. The BSP sets standards for the screening units and monitors performance through
its national quality assurance network.
In 2007, the Prime Minister announced plans for eventual extension to the range 47-73 years.
This offered another opportunity to obtain reliable evidence about the effects of extending
the age range of triennial screening. Hence, a trial of this age extension has begun, in
which only half are offered extra screening, with the effects monitored through routinely
collected NHS statistics.
Following a 2009-10 pilot study of the acceptability of cluster-randomisation of additional
screening at ages 47-49 and 71-73 in 5 breast screening units, the AgeX trial extended
recruitment to about five-sixths of the breast screening clinics in England, and this
cluster-randomisation continues.
In 2011, the Government deferred the earliest possible date when screening would be extended
to all women aged 47-73. Later, Public Health England (PHE, which is responsible for
government screening programmes) stated that final decisions about extension of the age range
would await the emergence of reliable evidence of its effects. The AgeX trial will eventually
provide this.
In 2012, an independent panel set up by the Department of Health and the charity Cancer
Research UK reported "The UK breast screening programmes [at ages 50-70] confer significant
benefit and should continue…. The impact of breast screening outside the ages 50-69 years is
very uncertain. The Panel supports the principle of the ongoing trial in the UK [AgeX] for
randomising women under age 50 and above age 70 to be invited for breast screening".
Meanwhile, as female life expectancy is increasing, interest has grown in the possible
advantages of continuing to screen women not just in their early 70s but throughout their
70s. The advantages and the disadvantages of continuing triennial screening after age 70
would be seen more clearly in a trial of 2 or 3 additional invitations (covering ages 71-76
or 71-79) than in a trial of just one.
In 2013 the All-Party Parliamentary Group on Breast Cancer in Older Women (APPG) said "Women
are not routinely invited for breast screening past the age of 70 … the current 'age
extension trial' [of screening past age 70] … should be extended past 73 to 76, and, if
appropriate … further extended". In a separate report in 2015 the APPG reiterated this
conclusion.
Although AgeX began as a trial of additional screening at ages 47-49 and at ages 71-73, it
has therefore become a trial in which the older women allocated additional screening can,
where resources are available, continue be invited triennially at ages 71-76 or at ages
71-79, thereby assessing the effects of continuing triennial screening for several years
after age 70.
