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

NCT06110845 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2023-11-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

QPlasia OncoReader Breast (QPORB)

Automated diagnostic algorithm

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • 4DPath

    collaborator UNKNOWN

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-11-30
Completion
2034-11-30
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110845 on ClinicalTrials.gov