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

NCT04365114 | Completed

• 1 other identifier: 50619
• Study Type: observational
• Target: 13,094,122
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Outcome Measures

Primary Outcomes (6)

• 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

• Cancers detected at screening

  Biopsy proven cancers detected at screening

  1 day screening episode

• False positive recalls

  Recall of women for further tests after screening which did not result in detection of cancer

  1 day screening episode

• Breast cancer mortality

  Mortality due to breast cancer (dependent on securing follow-on funding)

  13 years, and up to 30 years

• All cause mortality

  Mortality due to any cause (dependent on securing follow on funding)

  13 years, and up to 30 years

• 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 Outcomes (2)

• Breast cancer morbidity

  Up to 30 years

• Breast cancer free survival

  Up to 30 years follow-up

Study Arms (2)

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; Diagnostic Test: Test threshold

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: Breast screening mammography with two readers; Diagnostic Test: Test threshold

Interventions

Breast Screening Mammography with single reader DIAGNOSTIC_TEST

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

Single reading

Breast screening mammography with two readers DIAGNOSTIC_TEST

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

Double reading

Test threshold DIAGNOSTIC_TEST

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

Double reading; Single reading

Eligibility Criteria

• Age: 47 Years - 73 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warwick: lead
• Public Health England: collaborator

Study Sites (1)

Univesity of Warwick

Coventry, Warwickshire, CV47AL, United Kingdom

Location

Related Links

• Study website

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Speech Reception Threshold Test

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Audiometry, Speech; Audiometry; Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sian Taylor-Phillips, PhD

  University of Warwick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Screening and Test Evaluation

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: October 1, 2018
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)