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Completed

NCT Number: NCT04365114

Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening

Analysis of women's medical records to understand the impact of previous changes to breast cancer screening (increase from one to two clinicians examining each woman's mammograms, and what proportion of women they recall for further tests)

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Ductal Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

47 year–73 year

Sex eligibility

Female

Study type

Observational

Primary location

Univesity of Warwick

Coventry, Warwickshire, CV47AL, United Kingdom

About this study

Retrospective observational study examining the records and outcomes of women who attended breast cancer screening between 1988 and 2016. Linkage of records from the breast screening service, the cancer registry, and mortality. Analysis of whether changing the threshold for whether to recall women for further tests or the number of clinicians examining the mammograms for signs of cancer affects outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who attended the English National Health Service (NHS) breast cancer screening service at least once between 1988 and 2016, aged between 47 and 73
  • All eligible episodes of screening for each woman (we expect women to be screened around 7 times each)

Exclusion criteria

  • 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

Treatment and study plan

Breast Screening Mammography with single reader

Diagnostic Test

One clinician examined each woman's mammograms for signs of cancer

Breast screening mammography with two readers

Diagnostic Test

Two clinicians seperately examined each woman's mammograms for signs of cancer

Test threshold

Diagnostic Test

Threshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled

Primary outcomes

  1. Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method

    Time frame: 13 years, and up to 30 years

    Overdiagnosis of breast cancer (measured as difference in total cancer incidence, screen and symptomatic). Will also report mechanism of action (number of screen detected cancers, number of symptomatically detected cancers at 3,13, and 30 years follow-up)

  2. Cancers detected at screening

    Time frame: 1 day screening episode

    Biopsy proven cancers detected at screening

  3. False positive recalls

    Time frame: 1 day screening episode

    Recall of women for further tests after screening which did not result in detection of cancer

  4. Breast cancer mortality

    Time frame: 13 years, and up to 30 years

    Mortality due to breast cancer (dependent on securing follow-on funding)

  5. All cause mortality

    Time frame: 13 years, and up to 30 years

    Mortality due to any cause (dependent on securing follow on funding)

  6. Characteristics of cancer detected

    Time frame: 1 day screening episode, 3year, 13 year and up to 30 year follow up

    Size, grade and stage (reported overall, screen detected, and symptomatic detected).

Secondary outcomes

  1. Breast cancer morbidity

    Time frame: Up to 30 years

    Treatment received as a proxy for treatment associated morbidity (reported overall, screen detected and symptomatically detected, if follow on funding obtained)

  2. Breast cancer free survival

    Time frame: Up to 30 years follow-up

    Survival without a diagnosis of breast cancer

Sponsors and collaborators

Lead sponsor

University of Warwick

Other

Collaborators

  • Public Health England

Registry information

Official study title

Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening: an Observational Retrospective Cohort Study

Acronym: POSTBOx

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 28, 2020
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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