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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05925764
Other study ID # WSIGS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date October 31, 2023

Study information

Verified date June 2023
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the performance of a whole slide image based deep learning signature for predicting the novel grading system in resected lung adenocarcinoma based on a multicenter prospective cohort.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: 1. Pathological confirmation of primary lung adenocarcinoma; 2. Age ranging from 20-75 years; 3. Obtained written informed consent. Exclusion Criteria: 1. Multiple lung lesions; 2. Poor quality of whole slide images; 3. Participants with incomplete clinical information; 4. Mucinous adenocarcinomas and variants; 5. Participants who have received neoadjuvant therapy.

Study Design


Intervention

Diagnostic Test:
Whole Slide Image based Deep Learning Signature
Deep Learning Signature Based on Whole Slide Image for Predicting the Novel Grading System In Resected Lung Adenocarcinoma

Locations

Country Name City State
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Ningbo HwaMei Hospital Ningbo Zhejiang
China Affiliated Hospital of Zunyi Medical University Zunyi Guizhou

Sponsors (4)

Lead Sponsor Collaborator
Shanghai Pulmonary Hospital, Shanghai, China Ningbo HwaMei Hospital, Zhejiang, China, The First Affiliated Hospital of Nanchang University, Jiangxi, China, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Specificity The specificity of the deep learning model based on whole slide imge in predicting the novel grading system of resected lung adenocarcinoma. The novel grading system of lung adenocarcinoma includes grade I, grade II, and grade III. And the model will output the predictive values (grade I/grade II/grade III) of the grade for each patient with resected lung adenocarcinoma. 2023.5.1-2023.10.31
Other Positive predictive value The positive predictive value of the deep learning model based on whole slide imge in predicting the novel grading system of resected lung adenocarcinoma. The novel grading system of lung adenocarcinoma includes grade I, grade II, and grade III. And the model will output the predictive values (grade I/grade II/grade III) of the grade for each patient with resected lung adenocarcinoma. 2023.5.1-2023.10.31
Other Negative predictive value The negative predictive value of the deep learning model based on whole slide imge in predicting the novel grading system of resected lung adenocarcinoma. The novel grading system of lung adenocarcinoma includes grade I, grade II, and grade III. And the model will output the predictive values (grade I/grade II/grade III) of the grade for each patient with resected lung adenocarcinoma. 2023.5.1-2023.10.31
Other Accuracy The accuracy of the deep learning model based on whole slide imge in predicting the novel grading system of resected lung adenocarcinoma. The novel grading system of lung adenocarcinoma includes grade I, grade II, and grade III. And the model will output the predictive values (grade I/grade II/grade III) of the grade for each patient with resected lung adenocarcinoma. 2023.5.1-2023.10.31
Primary Area under the receiver operating characteristic curve The area under the receiver operating characteristic curve of the deep learning model based on whole slide imge in predicting the novel grading system of resected lung adenocarcinoma. The novel grading system of lung adenocarcinoma includes grade I, grade II, and grade III. And the model will output the predictive values (grade I/grade II/grade III) of the grade for each patient with resected lung adenocarcinoma. 2023.5.1-2023.10.31
Secondary Sensitivity The sensitivity of the deep learning model based on whole slide imge in predicting the novel grading system of resected lung adenocarcinoma. The novel grading system of lung adenocarcinoma includes grade I, grade II, and grade III. And the model will output the predictive values (grade I/grade II/grade III) of the grade for each patient with resected lung adenocarcinoma. 2023.5.1-2023.10.31
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