Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1014)

Recruiting

• Conditions: Lung Adenocarcinoma; Surgical Procedure, Unspecified; Pathology
• Interventions: Procedure: Surgical resection

• Registration Number: NCT05794698
• Lead Sponsor: Fudan University

Brief Summary

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1014). The goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (cT1N0M0) lung adenocarcinomas.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-04-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1063

Inclusion Criteria

• Patients who sign the informed consent form and are willing to complete the study according to the study protocol;
• No previous history of cancer or pulmonary surgery;
• Solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (GGO) on CT scan;
• Peripheral clinical T1N0M0 patients that are eligible for surgery;
• Non-small cell lung cancer is pathologically diagnosed before or at surgery;
• No radiation therapy or chemotherapy before surgery.

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Exclusion Criteria

• Patients with clinical stages other than T1N0M0;
• The lesion cannot be completely resected;
• Previous history of cancer;
• Patients having received radiation therapy or chemotherapy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Surgical resection	Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery.

Primary Outcome Measures

Name	Time	Method
Concordance rate	2 years	Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications.

Secondary Outcome Measures

Name	Time	Method
Concordance rate	2 years	Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of spread through air space (STAS).
Recurrence-free survival (RFS)	5 years	Recurrence-free survival (RFS) is defined as the time from date of curative surgery to the time of recurrence or death, whichever comes first.
Overall survival (OS)	5 years	Overall survival (OS) is defined as the time from date of curative surgery to the time of death of any reason.

Trial Locations

Locations (1)

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