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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04365114
Other study ID # 50619
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date December 30, 2023

Study information

Verified date May 2023
Source University of Warwick
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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)


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10000000
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 47 Years to 73 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Breast Screening Mammography with single reader
One clinician examined each woman's mammograms for signs of cancer
Breast screening mammography with two readers
Two clinicians seperately examined each woman's mammograms for signs of cancer
Test threshold
Threshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled

Locations

Country Name City State
United Kingdom Univesity of Warwick Coventry Warwickshire

Sponsors (2)

Lead Sponsor Collaborator
University of Warwick Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method 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
Primary Cancers detected at screening Biopsy proven cancers detected at screening 1 day screening episode
Primary False positive recalls Recall of women for further tests after screening which did not result in detection of cancer 1 day screening episode
Primary Breast cancer mortality Mortality due to breast cancer (dependent on securing follow-on funding) 13 years, and up to 30 years
Primary All cause mortality Mortality due to any cause (dependent on securing follow on funding) 13 years, and up to 30 years
Primary Characteristics of cancer detected 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 Breast cancer morbidity 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
Secondary Breast cancer free survival Survival without a diagnosis of breast cancer Up to 30 years follow-up
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