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

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

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 Overview

• Status: Completed
• Conditions: Lung Adenocarcinoma; Surgical Procedure, Unspecified; Pathology
• Intervention / Treatment: Procedure: Surgical resection

• Study Type: Observational
• Enrollment (Actual): 827

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Clinical stage T1N0M0 lung adenocarcinoma patients who are going to undergo surgical resection.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Clinical T1N0M0 lung adenocarcinoma patients eligible for surgery.	Procedure: Surgical resection; Surgical resection of lung adenocarcinoma. Wedge resection, segmentectomy or lobectomy will be performed according to each patients' condition.

What is the study measuring?

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 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 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 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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Shanghai Pulmonary Hospital, Shanghai, China; Zhoupu Hospital, Pudong New Area, Shanghai, China; Tongji Hospital, Wuhan, Hubei Province, China; Sixth People's Hospital, Shanghai, China; Ningbo Clinical Pathological Diagnostic Center, Ningbo, Zhejiang Province, China; Dongfang Hospital Affiliated to Tongji University, Shanghai, China; Minhang Hospital Affiliated to Fudan University, Shanghai, China; People's Hospital of Jiangdu, Yangzhou, Jiangsu Province, China; Liaocheng People's Second Hospital, Liaocheng, Shandong Province, China; Guanxian People's Hospital, Liaocheng, Shandong Province, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: surgical treatment; Lung adenocarcinoma; Intraoperative frozen section pathology
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: CONCORD-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No