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

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794698
• Other study ID #: CONCORD-A
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: Yue Zhao, M.D., Ph.D.
• Phone: +86 18801735510
• Email: yuezhao97[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1063
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• Pathology
• Surgical Procedure, Unspecified

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Center	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor

Collaborator

Fudan University

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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