HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma (ECTOP-1008)

Completed

• Conditions: Adenocarcinoma of Lung

• Registration Number: NCT04165759
• Lead Sponsor: Fudan University

Brief Summary

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1008). It aims to evaluate the correlation between radiological diagnosis based on HRCT and pathological invasiveness.Investigators observe the radiological features and the correlation with the postoperative pathological findings.

Detailed Description

Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured lung adenocarcinoma is important for selection of appropriate surgical extent. Whether thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor invasion (invasive adenocarcinoma \[IAD\] versus adenocarcinoma in situ \[AIS\]/minimally invasive adenocarcinoma \[MIA\]) would be evaluated according to radiologic parameters of HRCT before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study Start: 2019-11-18
• Study First Posted: 2019-11-18
• Primary Completion: 2021-04-30
• Study Completion: 2021-07-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

(1) GGNs on HRCT scan; (2) clinical stage IA; (3) simultaneously no more than three nodules; (5) Age ranging from 15 to 85 years.

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Exclusion Criteria

(1) pathologically confirmed non-adenocarcinoma; (2) patients who did not receive surgery.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	Pathologic reports were available, usually 1 month after surgery	Diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT

Secondary Outcome Measures

Name	Time	Method
Value of radiologic parameters for tumor invasion	Pathologic reports were available, usually 1 month after surgery	The receiver operating characteristic curve (ROC curve) and the area under the ROC curve (AUC) of the invasion prediction model based on radiologic parameters.

Trial Locations

Locations (2)

Fudan University Cancer Center; 🇨🇳 Shanghai, Shanghai, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China