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NCT05868252 Clinical Trial

Molecular Analysis of the Sloane Project

DCIS Clinical Trial

Official title:
Molecular Analysis of Screen Detected Non-invasive Breast Cancer and Atypical Breast Hyperplasias Identified by the Sloane Project

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05868252
Other study ID # 19/LO/0648
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date May 19, 2024

Study information
Verified date May 2023
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Sloane Project is a UK wide prospective audit of screen detected non-invasive and atypical breast hyperplasias named after John Sloane an eminent pathologist interested in the field. 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 but benign lesions found in 10% of benign biopsies performed through the NHS breast 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 (10 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 how best to manage these early lesions which can lead to breast cancer. All NHS breast screening units in the UK are invited to submit data for the Sloane Project. Historically an exceptional ~90% of centres in England, Scotland, Wales and Northern Ireland have participated on a voluntary basis. The objective of this research protocol is the collection of anonymised formalin fixed paraffin embedded (FFPE) tissue blocks from women whose data is held within the Sloane Project database in order to allow detailed analysis of the biological, molecular and genomic changes in these cases of in situ carcinoma and atypical hyperplasia and how these relate to the corresponding annotated clinical, pathological and radiological data already collected by and held in PHE. We seek to identify particular signature(s) that define which patients are likely to develop invasive disease, distinguishing the worrisome from indolent, non-worrisome lesions.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1500
Est. completion date May 19, 2024
Est. primary completion date May 19, 2024
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - DCIS (Ductal Carcinoma in situ) - LCIS (Lobular Carcinoma in situ) - Atypical hyperplasias

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom King's College London London

Sponsors (1)
Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression of breast disease From diagnosis to end of 2016
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