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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01081288
Recruitment Status : Active, not recruiting
First Posted : March 5, 2010
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
Public Health England
Cancer Research UK
Medical Research Council via core support
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE March 3, 2010
First Posted Date  ICMJE March 5, 2010
Last Update Posted Date September 3, 2020
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
Breast cancer mortality [ Time Frame: 17 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
  • Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ]
  • Hospital admissions for mastectomy and lumpectomy, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ]
  • All-cause mortality, up to the same date that the primary outcome (breast cancer mortality) is reported [ Time Frame: 17 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
Breast cancer registrations in the screened and unscreened groups [ Time Frame: 13 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extending the National Health Service (NHS) Breast Screening Age Range
Official Title  ICMJE Nationwide Cluster-randomised Trial of Extending the NHS Breast Screening Age Range in England
Brief Summary Nationwide cluster-randomised trial of extending the NHS breast screening age range in England
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer Mortality
Intervention  ICMJE Other: Invitation for breast screening
Invitation for breast screening to women in different age groups
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2020)
4000000
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2010)
1100000
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 47 Years to 73 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01081288
Other Study ID Numbers  ICMJE 10/H0710/9
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE
  • Public Health England
  • Cancer Research UK
  • Medical Research Council via core support
Investigators  ICMJE
Principal Investigator: Julietta Patnick, BA University of Oxford
PRS Account University of Oxford
Verification Date September 2020

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