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NCT Number: NCT04165759

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

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.

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Key information

Conditions

Adenocarcinoma of Lung Adenocarcinoma Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Cancer Center, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sensitivity

    Time frame: Pathologic reports were available, usually 1 month after surgery

    Diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT

Secondary outcomes

  1. Value of radiologic parameters for tumor invasion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Fujian Medical University Union Hospital
  • Jiangdu People's Hospital, Yangzhou
  • Shandong First Medical University Affiliated Liaocheng Second Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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