Cohort profile of the Sloane Project: methodology for a prospective UK cohort study of >15 000 women with screen-detected non-invasive breast neoplasia. Issue 12 (19th December 2022)

• Record Type: Journal Article
• Authors: Clements, Karen; Dodwell, David; Hilton, Bridget; Stevens-Harris, Isabella; Pinder, Sarah; Wallis, Matthew G; Maxwell, Anthony J; Kearins, Olive; Sibbering, Mark; Shaaban, Abeer M; Kirwan, Cliona; Sharma, Nisha; Stobart, Hilary; Dulson-Cox, Joanne; Litherland, Janet; Mylvaganam, Senthurun; Provenzano, Elena; Sawyer, Elinor; Thompson, Alastair M
• Is Part Of: BMJ open. Volume 12:Issue 12(2022)
• Publication Date: 2022-12-19
• Subjects: AUDIT -- Protocols & guidelines -- Breast tumours -- PUBLIC HEALTH -- STATISTICS & RESEARCH METHODS; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-061585
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Purpose: The introduction of breast screening in the UK led to an increase in the detection of non-invasive breast neoplasia, predominantly ductal carcinoma in situ (DCIS), a non-obligatory precursor of invasive breast cancer. The Sloane Project, a UK prospective cohort study of screen-detected non-invasive breast neoplasia, commenced in 2003 to evaluate the radiological assessment, surgical management, pathology, adjuvant therapy and outcomes for non-invasive breast neoplasia. Long-term follow-up and accurate data collection are essential to examine the clinical impact. Here, we describe the establishment, development and analytical processes for this large UK cohort study. Participants: Women diagnosed with non-invasive breast neoplasia via the UK National Health Service Breast Screening Programme (NHSBSP) from 01 April 2003 are eligible, with a minimum age of 46 years. Diagnostic, therapeutic and follow-up data collected via proformas, complement date and cause of death from national data sources. Accrual for patients with DCIS ceased in 2012 but is ongoing for patients with epithelial atypia/in situ neoplasia, while follow-up for all continues long term. Findings to date: To date, patients within the Sloane cohort comprise one-third of those diagnosed with DCIS within the NHSBSP and are representative of UK practice. DCIS has a variable outcome and confirms the need for longer-term follow-up for screen-detected DCIS. However, the radiology and pathology features of DCIS can be used to inform patient management. We demonstrate validation of follow-up information collected from national datasets against traditional, manual methods. Future plans: Conclusions derived from the Sloane Project are generalisable to women in the UK with screen-detected DCIS. The follow-up methodology may be extended to other UK cohort studies and routine clinical follow-up. Data from English patients entered into the Sloane Project are available on request to researchers under data sharing agreement. Annual follow-up data collection will continue for a minimum of 20 years.