NCT06110845Not yet recruiting
CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers (CLEOPATRAA)
CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers
Source: ClinicalTrials.gov · Last updated 1 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 26 Oct 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Diseases
- Childhood cancers
- NCT number
- NCT06110845
What you commit to
- Study type: Observational
- Planned participants: 800
- From 1 Dec 2023 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- 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).
Who the study is looking for
- all patients with a breast biopsy specimen processed at the pathology laboratory at SJUH, LTHT.
Age in the registry: 16 years to 110 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St James's University Hospital, Leeds Teaching Hospitals Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.