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

Adenocarcinoma of Lung Clinical Trial

Official title:

Preoperative Evaluation of High-resolution Computed Tomography to Predict Pathologic Tumor Invasion in Ground-glass Opacity Featured Lung Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165759
• Other study ID #: PRSHRCT
• Status: Completed
• Start date: November 18, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: July 1, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Fudan University	Fujian Medical University Union Hospital, Jiangdu People's Hospital, Yangzhou, Shandong First Medical University Affiliated Liaocheng Second Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT	Pathologic reports were available, usually 1 month after surgery
Secondary	Value of radiologic parameters for tumor invasion	The receiver operating characteristic curve (ROC curve) and the area under the ROC curve (AUC) of the invasion prediction model based on radiologic parameters.	Pathologic reports were available, usually 1 month after surgery