Breast Screening Atypia and Subsequent Development of Cancer in England
January 14, 2025 updated by: Sian Taylor-Phillips, University of Warwick
Breast Screening Atypia and Subsequent Development of Cancer: an Observational Analysis of the Sloane Database in England (Sloane Atypia Cohort Study)
During breast screening, atypical epithelial proliferations (atypia) can be detected.
These are not cancer, but may mean that a woman is more likely to develop breast cancer in the future.
This study explores how atypia develop into breast cancer in terms of number of women, time to cancer development, cancer type and severity, and whether this varies for different types of atypia.
The results will be used to create new guidelines for how women with atypia should be followed up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In England, breast cancer screening is offered every three years to women aged 50 to 70. In an increasing number of women atypical epithelial proliferations (atypias) are detected. Atypias are a heterogeneous group of abnormalities, which are not cancer but carry a low but significant rate of associated malignancy. Detecting these lesions has uncertain benefit because of insufficient evidence on their risk of subsequent development into breast cancer. This information is key to optimising follow-up and subsequent screening. This study undertakes the first analysis of the Sloane atypia data by reporting the proportion of women with atypia who develop breast cancer by type of atypia (atypical ductal hyperplasia (ADH) or atypical intraductal epithelial proliferation (AIDEP), flat epithelial atypia (FEA), and lobular in situ neoplasia (LISN: atypical lobular hyperplasia (ALH) and lobular carcinoma in situ (LCIS)) and in what time frame.
This large-scale study of atypia uses the English screening programme data from the Sloane cohort study. The Sloane atypia project is a prospective cohort of atypia diagnosed through the UK NHS Breast Screening Programme from April 2003 to the present. For this analysis, English screening units are included with radiology, histopathology, surgery and radiotherapy proformas. Subsequent development of breast cancer has been identified by matching women by NHS number and date of birth to the English Cancer Registry held by the National Cancer Registration and Analysis Service (NCRAS). The atypia cases are also matched to the Mortality and Birth Information System to collect mortality data for censoring follow-up, and the Breast Screening Data Repository for information on invitation and attendance at subsequent screening mammography appointments.
Study objectives are:
- To characterise atypia in terms of type, method of investigation and women's demographics;
- To determine breast cancer risk over time by type of atypia;
- To characterise the nature of subsequent cancers detected, and their prognostic features;
- To communicate results to clinicians and women;
- To recommend changes to the NHS Breast Screening Programme quality standards.
Study Type
Observational
Enrollment (Actual)
3238
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Warwickshire
-
Coventry, Warwickshire, United Kingdom, CV47AL
- Univesity of Warwick
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
47 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Women with atypia diagnosed during breast cancer screening in England between 1st January 2003 and 30th June 2018.
Description
Inclusion Criteria:
- Diagnosis of epithelial atypia (ADH (including AIDEP), LISN (both ALH and LCIS) and FEA) in the Sloane database between 1st January 2003 and 30th June 2018
Exclusion Criteria:
- bilateral primary cases
- the "best prognosis" atypia of the bilateral primaries
- atypia with co-existing DCIS
- pleomorphic LCIS (as these are managed akin to DCIS)
- unknown type of atypia
- cases not from England
- patients without follow-up until 31 December 2018
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Women attending Breast Cancer Screening in England with an atypia diagnosis
Women attending Breast Cancer Screening in England with an atypia diagnosis between 1st January 2003 and 30th June 2018
|
An atypia diagnosis of either ADH (including AIDEP), LISN (both ALH and LCIS) or FEA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Invasive breast cancer at 3 years following atypia diagnosis
Time Frame: Cumulative incidence of invasive breast cancer with all cause mortality as a competing risk at 3 years following atypia diagnosis
|
Invasive breast cancer rate at 3 years following atypia diagnosis (representing the first round of screening) for all atypia, by type of atypia, by level of management off atypia, by three 5-year periods (deviding study period into 2003 to 2007, 2008 to 2012 and 2013 to 2018), by location (ipsilateral, contralateral), by age group, and by complete vs incomplete reporting of atypia cases by screening centres
|
Cumulative incidence of invasive breast cancer with all cause mortality as a competing risk at 3 years following atypia diagnosis
|
|
Invasive breast cancer at 6 years following atypia diagnosis
Time Frame: Cumulative incidence of invasive breast cancer with all cause mortality as a competing risk at 6 years following atypia diagnosis
|
Invasive breast cancer rate at 6 years following atypia diagnosis (representing the second round of screening) for all atypia, by type of atypia, by level of management off atypia, by three 5-year periods (deviding study period into 2003 to 2007, 2008 to 2012 and 2013 to 2018), by location (ipsilateral, contralateral), by age group, and by complete vs incomplete reporting of atypia cases by screening centres
|
Cumulative incidence of invasive breast cancer with all cause mortality as a competing risk at 6 years following atypia diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Invasive breast cancer at 1-year following atypia diagnosis
Time Frame: Cumulative incidence of invasive breast cancer with all cause mortality as a competing risk at 1-year following atypia diagnosis
|
Invasive breast cancer rate at 1-year following atypia diagnosis (representing likely missed cancers at screening) for all atypia, by type of atypia, by level of management of atypia, by three 5-year periods (deviding study period into 2003 to 2007, 2008 to 2012 and 2013 to 2018), by location (ipsilateral, contralateral), by age group, and by complete vs incomplete reporting of atypia cases by screening centres
|
Cumulative incidence of invasive breast cancer with all cause mortality as a competing risk at 1-year following atypia diagnosis
|
|
Invasive cancer or non-invasive cancer (Ductal carcinoma in situ (DCIS)) at 1 year following atypia diagnosis
Time Frame: Cumulative incidence of invasive breast cancer or DCIS with all cause mortality as a competing risk at 1 year following atypia diagnosis
|
Rate of invasive breast cancer or DCIS at 1 year following atypia diagnosis for all atypia and by type and location of atypia
|
Cumulative incidence of invasive breast cancer or DCIS with all cause mortality as a competing risk at 1 year following atypia diagnosis
|
|
Invasive cancer or non-invasive cancer (Ductal carcinoma in situ (DCIS)) at 3 years following atypia diagnosis
Time Frame: Cumulative incidence of invasive breast cancer or DCIS with all cause mortality as a competing risk at 3 years following atypia diagnosis
|
Rate of invasive breast cancer or DCIS at 3 years following atypia diagnosis for all atypia and by type and location of atypia
|
Cumulative incidence of invasive breast cancer or DCIS with all cause mortality as a competing risk at 3 years following atypia diagnosis
|
|
Invasive cancer or non-invasive cancer (Ductal carcinoma in situ (DCIS)) at 6 years following atypia diagnosis
Time Frame: Cumulative incidence of invasive breast cancer or DCIS with all cause mortality as a competing risk at 6 years following atypia diagnosis
|
Rate of invasive breast cancer or DCIS at 6 years following atypia diagnosis for all atypia and by type and location of atypia
|
Cumulative incidence of invasive breast cancer or DCIS with all cause mortality as a competing risk at 6 years following atypia diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jenkinson D, Freeman K, Clements K, Hilton B, Dulson-Cox J, Kearins O, Stallard N, Wallis MG, Sharma N, Kirwan C, Pinder S, Provenzano E, Shaaban AM, Stobart H, McDonnell S, Thompson AM, Taylor-Phillips S. Breast screening atypia and subsequent development of cancer: protocol for an observational analysis of the Sloane database in England (Sloane atypia cohort study). BMJ Open. 2022 Jan 7;12(1):e058050. doi: 10.1136/bmjopen-2021-058050.
- Freeman K, Mansbridge A, Stobart H, Clements K, Wallis MG, Pinder SE, Kearins O, Shaaban AM, Kirwan CC, Wilkinson LS, Webb S, O'Sullivan E, Jenkins J, Wright S, Taylor K, Bailey C, Holcombe C, Wyld L, Edwards K, Jenkinson DJ, Sharma N, Provenzano E, Hilton B, Stallard N, Thompson AM, Taylor-Phillips S. Evidence-informed recommendations on managing breast screening atypia: perspectives from an expert panel consensus meeting reviewing results from the Sloane atypia project. Br J Radiol. 2024 Feb 2;97(1154):324-330. doi: 10.1093/bjr/tqad053.
- Freeman K, Jenkinson D, Clements K, Wallis MG, Pinder SE, Provenzano E, Stobart H, Stallard N, Kearins O, Sharma N, Shaaban A, Kirwan CC, Hilton B, Thompson AM, Taylor-Phillips S; Sloane Project Steering Group. Atypia detected during breast screening and subsequent development of cancer: observational analysis of the Sloane atypia prospective cohort in England. BMJ. 2024 Feb 1;384:e077039. doi: 10.1136/bmj-2023-077039.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2021
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
May 30, 2022
First Posted (Actual)
June 2, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 14, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SOC.04/20-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The investigators do not have Office for Data Release permissions to share these data more widely, but can assist other researchers in applying for access.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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