Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517979
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Prospective Validation of a Digital Pathology-based Artificial Intelligence Diagnostic Model for Pan-cancer Lymphatic Metastasis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this diagnostic test is to develop an artificial intelligence AI-based pan-cancer universal diagnostic model for detecting pathological lymph node metastasis LNM and prospectively evaluate its apllication value in the real-world clinical practice
Investigators will compare the diagnostic performance sensitivity specificity etc of the AI model and routine pathological report issued by pathologists to see if the AI model can improve the clinical workflow of pathological evaluation of cancer LNM in in the real world
Investigators will compare the diagnostic performance sensitivity specificity etc of the AI model and routine pathological report issued by pathologists to see if the AI model can improve the clinical workflow of pathological evaluation of cancer LNM in in the real world
Detailed Description:
Lymph node metastasis LNM is a common mode of cancer metastasis and accurate postoperative pathological lymph node staging is of great significance for further treatment and prognosis assessment However the current pathological evaluation of lymph nodes relies on manual examination by pathologists which has a relatively low diagnostic efficiency and is prone to missed-diagnosis for micro metastatic lesions
Therefore investigators are to develope an artificial intelligence AI-based diagnostic model for detecting pathological cancer lymph node metastasis based on deep learning algorithms and evaluate its apllication value in the real-world clinical settings
This study is a diagnostic test with no intervention measures planning to collect pathological slides of formalin-fixed paraffin-embedded lymph nodes resected from the enrolled patients and digitise them into whole-slide images WSIs The AI model will analyse the WSIs and generate pixel-level heatmaps and slide-level diagnostic results with or without LNM The routine pathological examination will be performed as usual These two processes will not interfere with each other And if there are inconsistency in slide-level classification between AI and routine pathological examination investigators would convene senior pathologists for discussion to make the final decision immunohistochemistry would be performed if necessary The final result will be presented to the patient in the form of a pathological report
Therefore investigators are to develope an artificial intelligence AI-based diagnostic model for detecting pathological cancer lymph node metastasis based on deep learning algorithms and evaluate its apllication value in the real-world clinical settings
This study is a diagnostic test with no intervention measures planning to collect pathological slides of formalin-fixed paraffin-embedded lymph nodes resected from the enrolled patients and digitise them into whole-slide images WSIs The AI model will analyse the WSIs and generate pixel-level heatmaps and slide-level diagnostic results with or without LNM The routine pathological examination will be performed as usual These two processes will not interfere with each other And if there are inconsistency in slide-level classification between AI and routine pathological examination investigators would convene senior pathologists for discussion to make the final decision immunohistochemistry would be performed if necessary The final result will be presented to the patient in the form of a pathological report
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None