Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Intelligence | Experimental | A deep learning based artificial intelligence diagnostic system(DOI:10.1093/neuonc/noaa163) |
|
| Practicing Pathologists | Active Comparator | One pathologist who has at least 5 years of experience |
|
| Gold Standard | Other | A committee composed of two expert pathologists who has at least 10 years of experience and one expert pathologist who has at least 15 years of experience |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence | Diagnostic Test | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Study Arms | The number of correctly diagnosed participants by study arms divided by the total number of participants | 1 week after the last patient's diagnosis is completed |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of Study Arms | Sensitivity and specificity of study arms for each type calculated by 2x2 tables | 1 week after the last patient's diagnosis is completed |
| Spearman Coefficient of Study Arms related to Gold Standard |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Jin, DR | Contact | 0086-13817841756 | ozlei91@126.com | |
| Yixin Ma, BA | Contact | 0086-18001781531 | 14301050150@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Cuiyun Wu, Ph.D | Huashan Hospital | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
Not provided
Not provided
All patients will be diagnosed by both AI and ordinary pathologists, thus performing a self-controlled study
Not provided
Not provided
The AI group, ordinary pathologists and gold standard group will not be informed of each other's results
| Practicing Pathologists | Diagnostic Test | The 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 |
|
| Gold Standard | Diagnostic Test | Firstly, 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 |
|
Spearman Correlation Analysis between Study Arms and Gold Standard
| 1 week after the last patient's diagnosis is completed |