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

NCT ID: NCT04365114

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13094122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2024-12-30

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Breast Cancer Ductal Carcinoma in Situ

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Breast Screening Mammography with single reader

Intervention Type DIAGNOSTIC_TEST

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

Test threshold

Intervention Type DIAGNOSTIC_TEST

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.

Breast screening mammography with two readers

Intervention Type DIAGNOSTIC_TEST

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

Test threshold

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Breast Screening Mammography with single reader

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

Intervention Type DIAGNOSTIC_TEST

Breast screening mammography with two readers

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

Intervention Type DIAGNOSTIC_TEST

Test threshold

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

47 Years

Maximum Eligible Age

73 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health England

OTHER_GOV

Sponsor Role collaborator

University of Warwick

OTHER

Sponsor Role lead

Responsible Party

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Sian Taylor-Phillips

Associate Professor of Screening and Test Evaluation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sian Taylor-Phillips, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Warwick

Locations

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Univesity of Warwick

Coventry, Warwickshire, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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50619

Identifier Type: -

Identifier Source: org_study_id

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