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

• ClinicalTrials.gov Identifier: NCT01081288
• Recruitment Status: Active, not recruiting
• First Posted: March 5, 2010
• Last Update Posted: January 9, 2023
• Sponsor: University of Oxford
• Collaborators: Public Health England; Cancer Research UK
• Information provided by (Responsible Party): University of Oxford

Tracking Information

• First Submitted Date: March 3, 2010
• First Posted Date: March 5, 2010
• Last Update Posted Date: January 9, 2023
• Study Start Date: June 2009
• Estimated Primary Completion Date: December 31, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 29, 2016): Breast cancer mortality [ Time Frame: 17 years ]
• Original Primary Outcome Measures (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 ]

Current Secondary Outcome Measures (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 (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: Extending the National Health Service (NHS) Breast Screening Age Range
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Breast Cancer Mortality

Intervention

Other: Invitation for breast screening

Invitation for breast screening to women in different age groups

Study Arms

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 1, 2020): 4000000
• Original Estimated Enrollment (submitted: March 4, 2010): 1100000
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: December 31, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 47 Years to 73 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01081288
• Other Study ID Numbers: 10/H0710/9
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oxford
• Original Responsible Party: Heather House, Clinical Trials and Research Governance, Oxford University
• Current Study Sponsor: University of Oxford
• Original Study Sponsor: Same as current

Collaborators

• Public Health England
• Cancer Research UK

Investigators

• Principal Investigator: Julietta Patnick, BA; University of Oxford

• PRS Account: University of Oxford
• Verification Date: January 2023