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NCT03759756 Clinical Trial

Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma

Artificial Intelligence Clinical Trial

Official title:
Application of Artificial Intelligence for Early Diagnosis of Esophageal Squamous Cell Carcinoma During Optical Enhancement Magnifying Endoscopy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03759756
Other study ID # 2018SDU-QILU-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date April 1, 2020

Study information
Verified date April 2020
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Esophageal squamous cell carcinoma is one of the most common malignant tumor of upper digestive tract. However, the detection rate and diagnosis accuracy of early esophageal squamous cell cancer is low. The aim of this study is to develop a computer-assisted diagnosis tool combining with optical magnifying endoscopy for early detection and accurate diagnosis of it.

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date April 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- high risk patients for esophageal cancer aged 18 years or older;

- Histologically verified early esophageal squamous cell cancer.

Exclusion Criteria:

- patients whose images of esophagus not suitable for the training, validation and testing the computer-assist diagnosis tool.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• AI presentation
AI presentation means the automatic diagnosis information of AI and AI presentation means it is visible in the group.
• no AI presentation
AI presentation means the automatic diagnosis information of AI and no AI presentation means it is invisible in the group.

Locations
Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the diagnosis efficiency of the AI model the sensitivity, specificity and accuracy of the AI model 12 months
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