Breast Screening Atypia and Subsequent Development of Cancer in England

Breast Cancer Clinical Trial

Official title:

Breast Screening Atypia and Subsequent Development of Cancer: an Observational Analysis of the Sloane Database in England (Sloane Atypia Cohort Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05402436
• Other study ID #: SOC.04/20-21
• Status: Active, not recruiting
• Start date: December 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: University of Warwick
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 47 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
United Kingdom	Univesity of Warwick	Coventry	Warwickshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Warwick	King's College London, The Leeds Teaching Hospitals NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Invasive breast cancer 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
Secondary	Invasive cancer or non-invasive cancer (Ductal carcinoma in situ (DCIS)) 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
Secondary	Invasive cancer or non-invasive cancer (Ductal carcinoma in situ (DCIS)) 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
Secondary	Invasive cancer or non-invasive cancer (Ductal carcinoma in situ (DCIS)) 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