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

NCT06110845 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HP22/152913
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Conditions

Breast Cancer

Keywords

Digital Pathology

Outcome Measures

Primary Outcomes (1)

• Concordance

  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

  1 year

Secondary Outcomes (1)

• Health Economics evaluation

  6 months

Other Outcomes (1)

• Long term follow-up

  10 years

Interventions

QPlasia OncoReader Breast (QPORB) DEVICE

Automated diagnostic algorithm

Eligibility Criteria

• Age: 16 Years - 110 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients biopsied for breast cancer

You may qualify if:

• all patients with a breast biopsy specimen processed at the pathology laboratory at SJUH, LTHT.

You may not qualify if:

• Age \<16 or \>110 years, non-carcinoma malignancies (e.g., sarcomas, malignant phyllodes tumours), carcinomas not arising from within the breast (e.g., cutaneous malignancies).

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• University of Leeds: collaborator
• 4DPath: collaborator

Study Sites (1)

St James's University Hospital, Leeds Teaching Hospitals Trust

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: December 1, 2023
• Primary Completion: November 30, 2024
• Study Completion (Estimated): November 30, 2034
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)