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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05221814
Other study ID # 2021ky228
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date January 1, 2023

Study information

Verified date January 2022
Source Jiangxi Provincial Cancer Hospital
Contact Haiyu Zhou
Phone +8613710342002
Email lungcancer@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to develop a deep-learning model to automatically classify pulmonary nodules based on white-light images and to evaluate the model performance. Besides, suitable operation could be chosen with the help of this model, which could shorten the time of surgery.


Description:

All white-light photographs of pulmonary nodules from phones of pathologically confirmed adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA) and invasive adenocarcinoma (IAC) were retrospectively collected from consecutive patients who underwent surgery between June 30, 2020 and September 15, 2021 at Guangdong Provincial People's Hospital.Finally, a total of 1037 white-light images from 973 individuals were included in the study. The entire dataset was divided into training and test datasets, which were mutually exclusive, using random sampling. Of these, 830 images were used as the training dataset and 104 images from were used as the test dataset. The CNN model was used in classifying images, namely, Resnet-50. For the CNN model, pretrained model with the ImageNet Dataset were adopted using transfer learning. After constructing the CNN models using the training dataset, the performance of the models was evaluated using the test dataset and the prospective validation dataset.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date January 1, 2023
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Male or female,18 years and older. 2. Patients haven't undergone any therapy. 3. The pulmonary nodules were confirmed AIS, MIA or IAC. 4. The sizes of pulmonary nodules were less than 3cm. 5. The images were jpg format. Exclusion Criteria: 1. Suffering from other tumor disease before or at the same time. 2. Images with poor quality or low resolution that precluded proper classification.

Study Design


Intervention

Diagnostic Test:
gross pathologic photo based deep learning model
Whether apply gross pathologic photo based deep learning model to predict pathologic subtype

Locations

Country Name City State
China Guagndong Provincial People's Hospital Guangzhou Guangdong
China Jiangxi Cancer Hospital Nanchang Jiangxi

Sponsors (2)

Lead Sponsor Collaborator
Jiangxi Provincial Cancer Hospital Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1. Pathological subtype According to WHO classification of pulmonary tumors in 2020, this study classify pulmonary tumors into adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA) and invasive adenocarcinoma (IAC). We would collect the reports of pathological type of pulmonary nodules after surgery. through study completion, an average of 2 year
Primary Area Under the Curve (AUC) The area under the ROC curve based the predicton efficency of model through study completion, an average of 2 year
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