Breast Screening Atypia and Subsequent Development of Cancer in England

NCT ID: NCT05402436

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3238 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-12-30

Brief Summary

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.

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:

1. To characterise atypia in terms of type, method of investigation and women's demographics;

2. To determine breast cancer risk over time by type of atypia;

3. To characterise the nature of subsequent cancers detected, and their prognostic features;

4. To communicate results to clinicians and women;

5. To recommend changes to the NHS Breast Screening Programme quality standards.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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

A diagnosis of atypia as part of the English screening programme

Intervention Type: OTHER

An atypia diagnosis of either ADH (including AIDEP), LISN (both ALH and LCIS) or FEA

Interventions

A diagnosis of atypia as part of the English screening programme

An atypia diagnosis of either ADH (including AIDEP), LISN (both ALH and LCIS) or FEA

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 47 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Warwick

OTHER

Sponsor Role: lead

Responsible Party

Sian Taylor-Phillips

Professor of Population Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Univesity of Warwick

Coventry, Warwickshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 34996804 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38265306 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38302129 (View on PubMed)

Other Identifiers

SOC.04/20-21

Identifier Type: -

Identifier Source: org_study_id