Intraoperative Frozen Section Pathology to Diagnose the IASLC Grades for Lung Adenocarcinoma (ECTOP-1014)

Fudan University827 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

827

Conditions

Lung Adenocarcinoma Surgical Procedure, Unspecified Pathology

Interventions

Surgical resectionPROCEDURE

Surgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy will be performed according to each patients' condition.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Concordance rate

Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion.

Time frame: 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

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 5 years

Data from ClinicalTrials.gov

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