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

Breast Cancer Clinical Trial

— POSTBOx  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04365114
• Other study ID #: 50619
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ

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

External Links

•   Study website