Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (CONCORD-C)

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05794724

Collaborator

(none)

1,063

Enrollment

Location

Anticipated Duration (Months)

44.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Adenocarcinoma Surgical Procedure, Unspecified Pathology	Procedure: Surgical resection

Study Design

Study Type:

Observational

Anticipated Enrollment :

1063 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Concordance Between Intraoperative Frozen Section Pathology and Postoperative Paraffin-embedded Pathology in Diagnosing Spread Through Air Space (STAS) of Lung Adenocarcinoma

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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).

Secondary Outcome Measures

Concordance rate [2 years]
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of IASLC grades of lung adenocarcinoma
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.
Concordance rate [2 years]
Concordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of pleural invasion and lymph node invasion.
Recurrence-free survival (RFS) [5 years]
Recurrence-free survival (RFS)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haiquan Chen, Professor, Fudan University

ClinicalTrials.gov Identifier:

NCT05794724

Other Study ID Numbers:

CONCORD-C

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haiquan Chen, Professor, Fudan University

Intraoperative frozen section pathology

Surgical treatment

Lung adenocarcinoma

Additional relevant MeSH terms:

Adenocarcinoma

Adenocarcinoma of Lung

Study Results

No Results Posted as of Apr 3, 2023