Deep Learning Model to Predict the Recurrence of Stage IA Invasive Lung Adenocarcinoma After Sub-lobar Resection (DL-Rec-ILA)

October 24, 2024 updated by: Xin Fan, First Affiliated Hospital of Chongqing Medical University
This study aims to develop a deep learning model based on noncontrast CT images to predict the recurrence risk of stage IA invasive lung adenocarcinoma after sub-lobar resection,which can serve as potential tool to assist thoracic surgeons in making optimal treatment decisions.The study will use existing CT data to train and validate the model, without requiring any additional intervention for the participants.

Study Overview

Detailed Description

This study is designed to develop a deep learning model to predict the recurrence risk of stage IA invasive lung adenocarcinoma after sub-lobar resection using noncontrast CT images. The best indications for sub-lobar resection in patients with early-stage LADC are still debated, making surgical method selection somewhat difficult. The deep learning model can noninvasively and objectively predict the recurrence risk of patients with stage IA ILADC following sub-lobectomy and are helpful in predicting prognosis of patients with stage IA ILADC after sub-lobectomy and can facilitate the choosing of the optimal surgery mode of these patients.

The study will utilize retrospective data from patients with stage IA invasive lung adenocarcinoma after sub-lobar resection . Noncontrast CT images will be collected at admission and used as inputs for the deep learning model. The model will be trained using convolutional neural networks (CNN) to identify patterns associated with recurrence.

In addition to model development, the study will also evaluate the model's performance on a separate validation cohort to assess generalizability. Statistical analyses will include performance metrics such as area under the receiver operating characteristic (ROC) curve (AUC) and precision-recall curve.

This study aims to provide a valuable tool for clinicians to make timely decisions in choosing the optimal therapeutic approach.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Chongqing
      • Yuzhong District, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients diagnosed with stage IA invasive lung adenocarcinoma (ILADC) who underwent preoperative chest CT scans and sub-lobar resection. The participants are not limited in age, include both males and females, and were treated at our institution. The patients of external testing cohort are from other institution.

Description

Inclusion Criteria:(i) pathological confirmation of LADC; (ii) undergoing sub-lobar resection (wedge resection or segmentectomy); (iii) CT scanning prior to surgery; (iv) pathological staging of IA; and (v) complete clinical and follow-up data.

-

Exclusion Criteria:(i) multiple primary LADC; and (ii) other pulmonary lesions that might interfere with the morphological assessment of tumors.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Training Cohort
Patients in this cohort diagnosed with stage IA invasive lung adenocarcinoma who underwent sub-lobar resection. This cohort is used to train the 3D deep learning model to predict recurrence risk.
Validation Cohort
Patients in this cohort with stage IA ILADC. It is used to validate the model performance internally and assess its generalization within the same institution。
Testing Cohort
Patients in this cohort from other institution. It is used to test the generalizability of the model in predicting recurrence risk in an independent dataset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Prediction Accuracy
Time Frame: October 2024
The primary outcome measure is the accuracy of the 3D deep learning model in predicting the recurrence of stage IA invasive lung adenocarcinoma after sub-lobar resection. Accuracy will be evaluated by comparing the model's predictions with actual patient outcomes using metrics such as sensitivity, specificity, and area under the ROC curve (AUC).
October 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

October 24, 2024

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022MSXM147 (Other Grant/Funding Number: Joint project of Chongqing Health Commission and Science and Technology Bureau)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to privacy concerns and institutional regulations, individual participant data (IPD) will not be shared with external researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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