Breast Screening Atypia and Subsequent Development of Cancer in England

NCT05402436 | Completed

• 1 other identifier: SOC.04/20-21
• Study Type: observational
• Target: 3,238
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Screening; Observational

Outcome Measures

Primary Outcomes (2)

• Invasive breast cancer 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

  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 Outcomes (4)

• Invasive breast cancer at 1-year following atypia diagnosis

  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

  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

  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

  Cumulative incidence of invasive breast cancer or DCIS with all cause mortality as a competing risk at 6 years following atypia diagnosis

Study Arms (1)

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

Other: A diagnosis of atypia as part of the English screening programme

Interventions

A diagnosis of atypia as part of the English screening programme OTHER

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

Women attending Breast Cancer Screening in England with an atypia diagnosis

Eligibility Criteria

• Age: 47 Years - 73 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with atypia diagnosed during breast cancer screening in England between 1st January 2003 and 30th June 2018.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warwick: lead
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• King's College London: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Univesity of Warwick

Coventry, Warwickshire, CV47AL, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 34996804 BACKGROUND

• 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.

  PMID: 38265306 BACKGROUND

• 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.

  PMID: 38302129 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Population Health

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 2, 2022
• Study Start: December 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)