Impact of artificial intelligence based scoring of hormone expression in breast cancer on treatment decision making.
- Conditions
- Malignant neoplasm of breast of unspecified site,
- Registration Number
- CTRI/2021/03/031926
- Lead Sponsor
- Applied Materials India PVT LTD
- Brief Summary
This is a prospective cross-sectional study that will be conducted on cases of breast carcinoma. Glass slides prepared from blocks containing tumour tissue would be stained by immunohistochemistry for ER, PR, and HER2/neu expressions and Ki 67. The IHC slides of ER, PR, HER2 neu and Ki 67 will be de-identified and coded. 4 pathologists will independently score ER, PR, Her 2/neu and Ki 67 expression.
The results of manual scoring will be compared with that of artificial intelligence (AI) based scoring. The scores of IHC expression of ER, PR, Her 2 and ki67 obtained manually from pathologists and AI-based algorithm will be provided to the blinded medical oncologist who will decide and chart out the treatment plan separately for both manual score and the AI-based score based on these biomarkers expression scores. The treatment plan for both arms will be compared to study the impact of the AI-based solutions on clinical decision making and planning of further treatment for a patient with breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 75
Female patients, post-surgery with diagnosed breast carcinoma subjected to immunohistochemical analysis of hormone receptors(ER, PR, Her2-neu and Ki67) on the breast specimen.
Cases were consent could not be obtained.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Utility and effectiveness of computer assisted artificial intelligence (AI) based analysis to objectively quantify the biomarker expression in breast cancer. 4 months
- Secondary Outcome Measures
Name Time Method Impact of AI based scoring in deciding therapy modulation in patient diagnosed with breast cancer. 4 months
Related Research Topics
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Trial Locations
- Locations (1)
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Kasturba Hospital🇮🇳Udupi, KARNATAKA, IndiaDr Brij Mohan Kumar SinghPrincipal investigator9663984859brij.singh@manipal.edu