Clinical Trials Directory

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UnknownNCT04671368

Diagnostic Efficiency of Artificial Intelligence for Surgical Neuropathology

A Multi-center, Prospective, Self-Controlled Diagnostic Accuracy Comparative Studies of Artificial Intelligence Diagnostic System for Surgical Neuropathology

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
141 (estimated)
Sponsor
Jinsong Wu · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a multi-center, prospective, self-controlled, diagnostic accuracy comparative study of Artificial Intelligence Diagnostic System for Surgical Neuropathology. The investigators will compare the diagnostic efficiency of Artificial Intelligence with that of practicing pathologists, and suppose that the diagnostic efficiency of artificial intelligence in prospective clinical data is no less than that of pathologists.

Detailed description

In this study, 141 patients will be recruited. After being enrolled, the patients will accept surgery and specimens for pathological analysis will be taken according to the routine treatment process. The histopathologic slides will then be digitized by a whole-slide scanner. The images will be reviewed by gold standard committee for evaluation of ground truth. And then be separately diagnosed by Artificial Intelligence Diagnostic System and practicing pathologists. So the investigators can compare the diagnostic efficiency of Artificial Intelligence with that of pathologists, thus understand the gap between artificial intelligence and actual clinical practice.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTArtificial IntelligenceThe investigators will use the Artificial Intelligence Diagnostic System to review the H&E stained slide of each patient and then report the classification of the tumor on a 10-type scale.
DIAGNOSTIC_TESTPracticing PathologistsThe ordinary pathologist will review the H&E stained slide of each patient(without additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale only bases on the slide images
DIAGNOSTIC_TESTGold StandardFirstly, the two expert pathologist(\>=10 years of experience) will review the H&E stained slide of each patient on their own (with additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale.If they report the same opinion, that opinion will perform as the ground truth; while if their opinion clash with each other, the expert pathologist(\>=15 years of experience) will get involved and the agreement of three experts will perform as the ground truth

Timeline

Start date
2021-02-01
Primary completion
2022-02-01
Completion
2022-02-01
First posted
2020-12-17
Last updated
2020-12-17

Source: ClinicalTrials.gov record NCT04671368. Inclusion in this directory is not an endorsement.