NCT04365114

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13,094,122 (actual)
• Sponsor: University of Warwick · Academic / Other
• Sex: Female
• Age: 47 Years – 73 Years
• Healthy volunteers: Accepted

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)

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.

Conditions

• Breast Cancer
• Ductal Carcinoma in Situ

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Breast Screening Mammography with single reader	One clinician examined each woman's mammograms for signs of cancer
DIAGNOSTIC_TEST	Breast screening mammography with two readers	Two clinicians seperately 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

Timeline

• Start date: 2018-10-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2020-04-28
• Last updated: 2025-01-24

Locations

1 site across 1 country: United Kingdom