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

NCT ID: NCT04165759

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

620 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-07-01

Brief Summary

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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

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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.

Conditions

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Adenocarcinoma of Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

Patients with lung cancer who are candidates for surgery.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University Union Hospital

OTHER

Sponsor Role collaborator

Shandong First Medical University Affiliated Liaocheng Second Hospital

UNKNOWN

Sponsor Role collaborator

Jiangdu People's Hospital, Yangzhou

UNKNOWN

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Haiquan Chen

Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haiquan Chen

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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PRSHRCT

Identifier Type: -

Identifier Source: org_study_id

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