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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04165759
Other study ID # PRSHRCT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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