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Extending the National Health Service (NHS) Breast Screening Age Range (AgeX)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Department of Health UK via Public Health England
Cancer Research UK via quinquennial core support
Medical Research Council via core support
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01081288
First received: March 3, 2010
Last updated: November 29, 2016
Last verified: November 2016

March 3, 2010
November 29, 2016
June 2009
December 2026   (final data collection date for primary outcome measure)
Breast cancer mortality [ Time Frame: 17 years ] [ Designated as safety issue: No ]
Mortality from breast cancer by age 60 for women invited to have an additional early screen (before age 50) versus those not invited, and by age 80 for women invited to have an additional late screen (after age 70) versus those not invited [ Time Frame: 13 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01081288 on ClinicalTrials.gov Archive Site
  • Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ] [ Designated as safety issue: No ]
  • Hospital admissions for mastectomy and lumpectomy, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ] [ Designated as safety issue: No ]
  • All-cause mortality, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ] [ Designated as safety issue: No ]
Breast cancer registrations in the screened and unscreened groups [ Time Frame: 13 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Extending the National Health Service (NHS) Breast Screening Age Range
Nationwide Cluster-randomised Trial of Extending the NHS Breast Screening Age Range in England
Nationwide cluster-randomised trial of extending the NHS breast screening age range in England

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer Mortality
Other: Invitation for breast screening
Invitation for breast screening to women in different age groups
  • Active Comparator: Women aged 47-49 invited for breast screening
    Intervention: Other: Invitation for breast screening
  • Active Comparator: Women aged 71-73 invited for breast screening
    Intervention: Other: Invitation for breast screening
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
6000000
December 2026
December 2026   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female, and
  • Aged 47-49 years or 71-73 years, and
  • In a Breast Screening Unit participating in the study. (All Breast Screening Units in England are expected to participate in the study with the exception of a few that use non-standard methods for creating screening batches).

Exclusion Criteria:

  • Anyone not satisfying the inclusion criteria
Female
47 Years to 73 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01081288
10/H0710/9
Yes
Not Provided
Not Provided
University of Oxford
University of Oxford
  • Department of Health UK via Public Health England
  • Cancer Research UK via quinquennial core support
  • Medical Research Council via core support
Principal Investigator: Julietta Patnick, BA University of Oxford
University of Oxford
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP