CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers (CLEOPATRAA)

The goal of this non-interventionist observational study is to test the performance of a computer algorithm (QPORB) which examines breast cancer biopsy digital images to provide diagnostic support. The main question\[s\] it aims to answer are: 1. The principal research aim is to determine whether 4D Path's Technology Q-Plasia OncoReader Breast, that has been developed in the research setting, works robustly in the clinical environment (i.e. to define its real-life clinical utility) in terms of breast carcinoma grading and molecular subtyping 2. The secondary research aim is to perform an economic analysis alongside the trial in order to establish the time, resource and cost savings that the technology could afford the NHS, the ideal price point for engaging with the technology and the cost:benefit ratio for evaluation by the National Institute for Clinical Excellence 3. The tertiary research aim is to gather long-term follow-up data to better understand long-term response to therapy and prognosis and potential future uses of the algorithm Participants's specimens will be tested alongside routine clinical workflows without intervention or consent. Researchers will compare the algorithm's results to those of routine diagnostic standard of care workflows.

NCT Number	NCT06110845
Lead Sponsor	The Leeds Teaching Hospitals NHS Trust Collaborators: University of Leeds, 4DPath
Conditions	Breast Cancer
Enrollment	800 participants
Start Date	2023-12-01
Primary Completion	2024-11-30 (estimated)
Study Completion	2034-11-30 (estimated)
Updated on ClinicalTrials.gov	2023-11-01