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

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ClinicalTrials.gov Identifier: NCT01081288
Recruitment Status : Enrolling by invitation
First Posted : March 5, 2010
Last Update Posted : November 30, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Nationwide cluster-randomised trial of extending the NHS breast screening age range in England

Condition or disease Intervention/treatment
Breast Cancer Mortality Other: Invitation for breast screening

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nationwide Cluster-randomised Trial of Extending the NHS Breast Screening Age Range in England
Study Start Date : June 2009
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Women aged 47-49 invited for breast screening Other: Invitation for breast screening
Invitation for breast screening to women in different age groups
Active Comparator: Women aged 71-73 invited for breast screening Other: Invitation for breast screening
Invitation for breast screening to women in different age groups

Outcome Measures

Primary Outcome Measures :
  1. Breast cancer mortality [ Time Frame: 17 years ]

Secondary Outcome Measures :
  1. Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ]
  2. Hospital admissions for mastectomy and lumpectomy, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ]
  3. All-cause mortality, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   47 Years to 73 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081288

United Kingdom
Cancer Epidemiology Unit, Richard Doll Building, University of Oxford, Roosevelt Drive
Oxford, United Kingdom, OX3 7LF
Sponsors and Collaborators
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
More Information

Additional Information:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01081288     History of Changes
Other Study ID Numbers: 10/H0710/9
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Keywords provided by University of Oxford:
Breast cancer
Breast screening
Routine screening programme