English Mammography Screening Outcomes by Age, Frequency and Test Threshold

NCT05247463 | Unknown

• 1 other identifier: SOC.03/20-21
• Study Type: observational
• Target: 10,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer screening involves taking mammograms (x-rays) of women's breasts to search for signs of cancer. This study investigates the impact of test threshold, screening interval (frequency) and age of eligibility on intermediate outcomes, and health outcomes such as mortality and morbidity. This observational study links breast cancer screening, cancer registry and mortality registration data to answer these questions.

Conditions

Breast Cancer

Keywords

Screening; Observational

Outcome Measures

Primary Outcomes (12)

• Breast Cancer Specific Mortality

  Breast Cancer Specific Mortality

  Cumulative incidence of breast cancer specific mortality over all follow-up time (up to maximum 30 years)

• Breast Cancer Specific Mortality

  Breast Cancer Specific Mortality

  10 year follow up of particular importance to match previous systematic review of results

• Breast Cancer Specific Mortality

  Breast Cancer Specific Mortality

  13 year follow up of particular importance to match previous systematic review of results

• All cause mortality

  All cause mortality

  Cumulative incidence of all-cause mortality over all follow-up time (up to maximum 30 years)

• All cause mortality

  All cause mortality

  10 year follow up of particular importance to match breast cancer mortality

• All cause mortality

  All cause mortality

  13 year follow up of particular importance to match breast cancer mortality

• Overdiagnosis

  Overdiagnosis of breast cancer which would not have been detected symptomatically using compensatory drop method, (difference between cumulative incidence of cancer (screening and symptomatic) between exposure groups

  Cumulative incidence of cancer over all follow-up time (up to maximum 30 years)

• Overdiagnosis

  Overdiagnosis of breast cancer which would not have been detected symptomatically using compensatory drop method, (difference between cumulative incidence of cancer (screening and symptomatic) between exposure groups

  10 year follow up of particular importance to match breast cancer mortality

• Overdiagnosis

  Overdiagnosis of breast cancer which would not have been detected symptomatically using compensatory drop method, (difference between cumulative incidence of cancer (screening and symptomatic) between exposure groups

  13 year follow up of particular importance to match breast cancer mortality

• Stage Shift

  Difference in prognostic indicators (DCIS vs invasive, grade, size, nodes involved, cancer type, hormonal status, Nottingham Prognostic Index, distant metastasis) between exposure groups, including both symptomatically and screen detected cancers

  For breast cancers detected at any point during follow-up (up to a maximum 30 years)

• Treatment Received

  Breast Cancer Treatment received (as a proxy for treatment associated morbidity)

  Within 1 year of diagnosis

• False positive recall to assessment

  Proportion of women recalled for further tests from their screening mammogram, in whom those further tests did not detect breast cancer

  At point of screening episode

Secondary Outcomes (3)

• Interval cancers

  Up to 3 years after the screening appointment

• Cancers detected at screening

  At screening episode

• Screen detected cancer characteristics

  At screening episode

Study Arms (2)

Women invited to Breast Cancer Screening in England

Women invited to Breast Cancer Screening in England up to 31st March 2018

Other: Increase in upper age of eligibility for breast cancer screening from 64 to 70

Women attending Breast Cancer Screening in England

Women attending mammography screening to examine the effect of screening test threshold on outcomes, up to 31st March 2018

Other: Screening round length; Diagnostic Test: Screening test threshold

Interventions

Increase in upper age of eligibility for breast cancer screening from 64 to 70 OTHER

The upper age limit of eligibility for Breast Cancer Screening increased in England from 64 to 70 as a result of the NHS Cancer Plan, so women were offered an additional 2 rounds of screening.

Women invited to Breast Cancer Screening in England

Screening round length OTHER

The target round length (frequency) of breast cancer screening in England is every 3 years. However in practice there is variability in this due to local centre capacity. The exposures are round lengths of approximately 2 years and approximately 3 years

Women attending Breast Cancer Screening in England

Screening test threshold DIAGNOSTIC_TEST

Radiologists and equivalent health professionals examine women's screening mammograms for potential signs of cancer, and recall some women for further diagnostic tests. Each has a different test threshold for recall, characterised by the proportion of previous cases that they have recalled.

Women attending Breast Cancer Screening in England

Eligibility Criteria

• Age: 47 Years - 73 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women invited for a Breast Cancer Screening appointment in England between 1st January 1988 and 31st March 2018. For test threshold and screening interval data this is further limited to women attending at least one breast screening appointment meeting the age and date eligibility requirements. The population will be further limited to women invited for breast cancer screening after 1st January 1998, if accurate data linkage cannot be achieved before this date in the absence of a unique identifier (before the widespread implementation of NHS number)

You may qualify if:

• Women invited for breast cancer screening by the English NHS Breast Screening Programme

You may not qualify if:

• Missing or corrupted data for NHS number, so linkage between databases is not possible
• For analysis of test threshold and screening interval: women who did not attend routine English NHS Breast screening service within the specified date and age range, even if they attended symptomatic breast cancer services, high risk (family history) breast screening services, or if they were referred for mammograms by their general practitioner

Sponsors & Collaborators

• University of Warwick: lead
• University of Birmingham: collaborator
• University of Bristol: collaborator

Study Sites (1)

University of Warwick

Coventry, Warwickshire, CV47AL, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Population Health

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 18, 2022
• Study Start: January 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)