Screening Quality Assurance Service, NHS England, Birmingham, UK
Nuffield Department of Population Health, University of Oxford, Oxford, UK.
BMJ Open. 2022 Dec 19;12(12):e061585. doi: 10.1136/bmjopen-2022-061585.
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.
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.
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.
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.
英国引入乳房筛查导致非浸润性乳腺肿瘤（主要为导管原位癌，DCIS）的检出率增加，DCIS 是浸润性乳腺癌的非强制性前体。Sloane 项目是英国一项针对筛查发现的非浸润性乳腺肿瘤的前瞻性队列研究，于 2003 年启动，旨在评估非浸润性乳腺肿瘤的影像学评估、手术管理、病理、辅助治疗和结果。长期随访和准确的数据收集对于检查临床影响至关重要。在此，我们描述了这项大型英国队列研究的建立、发展和分析过程。
符合条件的女性为通过英国国家医疗服务体系（NHS）乳腺筛查计划（NHSBSP）诊断为非浸润性乳腺肿瘤的患者，最小年龄为 46 岁。通过预印本收集诊断、治疗和随访数据，辅以国家数据来源的日期和死亡原因。2012 年停止了对 DCIS 患者的入组，但对上皮不典型/原位肿瘤患者的入组仍在继续，所有患者的随访将长期进行。
迄今为止，Sloane 队列中的患者占 NHSBSP 中诊断为 DCIS 患者的三分之一，代表了英国的实践情况。DCIS 的结果具有变异性，证实需要对筛查发现的 DCIS 进行更长时间的随访。然而，DCIS 的影像学和病理学特征可用于指导患者管理。我们证明了从国家数据集收集的随访信息与传统的手动方法的一致性。
Sloane 项目得出的结论可推广至英国具有筛查发现的 DCIS 的女性。该随访方法可以扩展到其他英国队列研究和常规临床随访。根据数据共享协议，可应要求向研究人员提供已入组 Sloane 项目的英国患者的数据。每年的随访数据收集将至少持续 20 年。
