Patient Outcomes From Second Film-readers and Test Threshold Relaxation in Breast Screening (POSTBOx)

May 18, 2023 updated by: Sian Taylor-Phillips, University of Warwick

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

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)

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

10000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV47AL
        • Univesity of Warwick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Women who attended the English NHS Breast screening programme between 1988 and 2016 aged between 47 and 73.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single reading
Only one clinician examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not.
Diagnostic test: Breast Screening Mammography with single reader
One clinician examined each woman's mammograms for signs of cancer
Diagnostic test: Test threshold
Threshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled
Double reading
Two clinicians examined the woman's mammograms for signs of cancer and recommended whether to recall her for further tests or not.
Diagnostic test: Test threshold
Threshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled
Diagnostic test: Breast screening mammography with two readers
Two clinicians seperately examined each woman's mammograms for signs of cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
13 years, and up to 30 years
Cancers detected at screening
Time Frame: 1 day screening episode
Biopsy proven cancers detected at screening
1 day screening episode
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
1 day screening episode
Breast cancer mortality
Time Frame: 13 years, and up to 30 years
Mortality due to breast cancer (dependent on securing follow-on funding)
13 years, and up to 30 years
All cause mortality
Time Frame: 13 years, and up to 30 years
Mortality due to any cause (dependent on securing follow on funding)
13 years, and up to 30 years
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).
1 day screening episode, 3year, 13 year and up to 30 year follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 30 years
Breast cancer free survival
Time Frame: Up to 30 years follow-up
Survival without a diagnosis of breast cancer
Up to 30 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Warwick

Collaborators

Public Health England

Investigators

  • Principal Investigator: Sian Taylor-Phillips, PhD, University of Warwick

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not have Office of Data Release permissions to share these data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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