|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
24 August 2020 |
|
Main ID: |
ChiCTR2000035860 |
|
Date of registration:
|
2020-08-18 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Artificial intelligence for pathological grading system of ganglion cells for intraoperative rapid biopsy in Hirschsprung disease
|
|
Scientific title:
|
Artificial intelligence for pathological grading system of ganglion cells for intraoperative rapid biopsy in Hirschsprung disease |
|
Date of first enrolment:
|
2020-10-01 |
|
Target sample size:
|
Target condition:138;Difficult condition:138 |
|
Recruitment status: |
Pending |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=58640 |
|
Study type:
|
Diagnostic test |
|
Study design:
|
Factorial
|
|
Phase:
|
0
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Zhang Minzhong
|
|
Address:
|
1665 Kongjiang Road, Yangpu District, Shanghai, China
|
|
Telephone:
|
+86 18516057500 |
|
Email:
|
zhangminzhong@outlook.com |
|
Affiliation:
|
Xinhua Hospital, Shanghai Jiaotong University School of Medicine |
|
|
Name:
|
Zhang Minzhong
|
|
Address:
|
1665 Kongjiang Road, Yangpu District, Shanghai, China
|
|
Telephone:
|
+86 18516057500 |
|
Email:
|
zhangminzhong@outlook.com |
|
Affiliation:
|
Xinhua Hospital, Shanghai Jiaotong University School of Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Patients with histopathologically confirmed Hirchsprung Disease, including short-segment HSCR, long-segment HSCR and total colon aganglionosis.
2. Complete clinical data and pathological information;
3. Patients who signed written informed consent to participate in the study.
Exclusion criteria: 1. The pathologic diagnosis is intestinal neuronl dysplasia;
2. The pathologic diagnosis is chronic intestinal pesudo-obstruction.
3. Combined with chromosomal abnormalities and other congenital disorders.
Age minimum:
0
Age maximum:
16
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hirschsprung disease
|
|
Intervention(s)
|
|
Gold Standard:The speciemens and sections will be reveiwed by three senior pediatric gastroenterology pathologists under the novel pathological grading system of ganglion cells in Hirschsprung disease, and the results is regarded as the gold standard.;Index test:Artificial intelligence assisted whole-section patholgic diagnosis system;
|
|
Primary Outcome(s)
|
|
the area under the receiver operating characteristic (AUC);Accuracy;Sensitivity;Specificity;Positive predictive values;Negative predictive values;
|
|
Source(s) of Monetary Support
|
|
Science and Technology Commission of Shanghai Municipality (19411968900)
|
|
Ethics review
|
Status: Approved
Approval date: 14/08/2020
Contact:
Shi Min
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|