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Evaluating the Net Effects of Extending the Age Range for Breast Screening in the NHS Breast Screening Programme in England From 50-70 Years to 47-73 Years


N/A
47 Years
73 Years
Open (Enrolling by invite only)
Female
Breast Cancer Mortality

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Trial Information

Evaluating the Net Effects of Extending the Age Range for Breast Screening in the NHS Breast Screening Programme in England From 50-70 Years to 47-73 Years


Currently all women aged 50-70 are invited for breast screening every three years. In 2007
the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme
(NHSBSP) would cover women aged 47-73. As capacity does not allow for full immediate roll
out across the whole of England, this age extension is being phased-in with full coverage
intended from 2012 although this may now be delayed due to slower than expected introduction
of digital mammography.

To date there is limited evidence on the net benefit of extending (up or down) the age range
for breast screening; no trial has looked at the added value of one extra screen within an
existing screening programme.

This study will involve randomising the phasing-in of the age extension and collecting
information on breast cancer incidence and mortality over the following 10 years. This will
provide unbiased evidence on the net effects of extending the age range for breast
screening. The findings have the potential to inform future screening policy in the UK and
elsewhere.

As part of the routine breast screening programme, screening invitation batches are created
of on average 1,000 women spanning ages 50 to 70 years, all living in the same geographical
locality. In this study slightly larger batches will be created of women aged 47 to 73
years. These batches will be randomly allocated to one of two groups, that is, to include
either women aged 47-70 or women aged 50-73 years. The study participants are the women aged
47-49 and 71-73 in these screening batches. All Breast Screening Units in England will
participate in the study with the exception of a few using a non-standard method to invite
women for screening.

The study builds on the pilot study (Pilot study of the feasibility and acceptability of
randomising the phasing-in of the age extension of the NHS Breast Screening Programme in
England. NCT00890864) which has been investigating the feasibility and acceptability of
randomising the phasing-in of the age extension in several pilot sites.

In January 2011 the Department of Health announced in Improving Outcomes: A Strategy for
Cancer that phasing-in of the age extension would continue over at least 2 three-year
screening rounds (rather than one as originally planned). Thus recruitment of women will
continue until at least 2016. As a result more women will now be included in the trial. The
study design remains the same. As women are now being randomised until at least 2016 (rather
than 2012) follow-up will continue at least until the late 2020s. In Dec 2010 North London
Research Ethics Committee 3 gave written agreement for a) the trial to be extended for
another 3 years and b) inclusion of data from the women in the pilot study (09/H0710/2) in
this trial.


Inclusion Criteria:



- Female,

- aged 47-49 or 71-73 years, and in a Breast Screening Unit participating in the study.

- All Breast Screening Units in England will participate in the study with the
exception of a few that use a non-standard batch creation system.

Exclusion Criteria:

- Anyone not satisfying the inclusion criteria

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

13 years

Safety Issue:

No

Principal Investigator

Julietta Patnick, BA(Hons)

Investigator Role:

Principal Investigator

Investigator Affiliation:

NHS Cancer Screening Programmes; also, Oxford University

Authority:

United Kingdom: Research Ethics Committee

Study ID:

10/H0710/9

NCT ID:

NCT01081288

Start Date:

March 2010

Completion Date:

December 2026

Related Keywords:

  • Breast Cancer Mortality
  • Breast cancer
  • Breast screening
  • Mammography
  • Routine screening programme
  • Breast Neoplasms

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