Molecular analysis of screen detected non-invasive breast cancer and atypical breast hyperplasias identified by the Sloane Project

This ethics application is a continuation of the project titled: Generation of ductal carcinoma in situ prognostic gene signature using retrospective archived paraffin embedded tumour samples. The study was given ethical approval on November 2008 by West Glasgow Ethics Committee 1 ( REF 08/S0703/147) The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias. Non invasive breast neoplasia accounts for 25% of all ‘breast cancers’ detected through breast screening and includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS). Atypical hyperplasias are high risk benign lesions and are found in 10% of benign biopsies performed through the screening programme. The importance of these lesions rests on the increased risk of subsequently developing invasive breast cancer with DCIS at highest risk ( 20 times greater than the general population) followed by LCIS (2-11 times greater) and atypical breast hyperplasia (4 times greater). The Sloane project data are held by Public Health England (PHE) and provide full and detailed information about the patients' journey from diagnosis to treatment and outcome. The project aims to increase the understanding of these early breast lesions which can lead to breast cancer. All NHS breast screening units in the UK are invited to send in data for the Sloane Project. The objective of this research protocol is the collection of formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project in order to allow detailed analysis of the genomic changes in cases of in situ and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data collected by PHE in order to identify a particular signature that define which cases are likely to develop invasive disease.