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

Study Overview
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Brief Summary
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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.

Official Title
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Concordance Between Intraoperative Frozen Section and Postoperative Pathology in Diagnosing the Subtype of Lung Adenocarcinoma and Guiding the Surgical Procedure of Lung Adenocarcinoma: a Multi-center Prospective Study

Conditions
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Lung Adenocarcinoma, Surgical Procedure, Unspecified, Pathology

Intervention / Treatment
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* Procedure: Surgical resection


Participation Criteria
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Eligibility Criteria
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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. 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery. | Procedure: Surgical resection<br>* Surgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy will be performed according to each patients' condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance rate | Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance rate | Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion. | 2 years | 
| Concordance rate | Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma | 2 years | 
| Concordance rate | Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of spread through air space (STAS). | 2 years | 
| Recurrence-free survival (RFS) | Recurrence-free survival (RFS) is defined as the time from date of curative surgery to the time of recurrence or death, whichever comes first. | 5 years | 
| Overall survival (OS) | Overall survival (OS) is defined as the time from date of curative surgery to the time of death of any reason. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative frozen section pathology, surgical treatment, Lung adenocarcinoma