sing artificial intelligence to help doctors and scientists in the lab that studies diseases in the body, in order to use less of a specific testing method called immunohistochemistry and make the work process smoother and more efficient.
- Conditions
- Reduction of immunohistochemistry used for the diagnosis of lymph node metastases in breast cancer (BCa - CONFIDENT-B), and prostate cancer (PCa - CONFIDENT-P) in prostate needle biopsies.Not Applicable
- Registration Number
- ISRCTN14323711
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 260
Health professionals:
1.1. PCa: dedicated uropathologists
1.2. BCa: dedicated breast pathologists
Patients:
1.1. PCa: adult males of any age undergoing prostate needle biopsies at the investigation site will be enrolled in the study and have their diagnosis determined in a prospective, consecutive manner.
1.2. BCa: adult females or males of any age with breast cancer as primary malignancy whose SN-specimen is assessed at the investigation site will be enrolled in the study and have their diagnosis determined in a prospective, consecutive manner.
2. All specimens that are H&E-stained and glass or film cover-slipped will be evaluated. Adjacent unstained slides will available for IHC staining.
3. The WSIs fulfill the quality checks described in the scanner manufacturer’s Instruction for Use and general clinical practice.
4. No diagnostic markings and patient identifiable markings are visible on the slides.
1. Patients who were referred for a second opinion
2. Patients that have opted out of all medical research
3. Cases in which the associated IHC-stained slides are unavailable/cannot be generated
4. Cases not meeting defined quality criteria for digital clinical primary diagnosis evaluation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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