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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05794698
Enrollment
827
Registered
2023-04-03
Start date
2022-01-01
Completion date
2024-08-30
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Adenocarcinoma, Pathology, Surgical Procedure, Unspecified

Keywords

Intraoperative frozen section pathology, surgical treatment, Lung adenocarcinoma

Brief 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.

Interventions

PROCEDURESurgical resection

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Concordance rate2 yearsConcordance rate between intraoperative frozen section and postoperative paraffin embedded pathology in making the diagnosis of lung adenocarcinoma subtypes according to the WHO classifications.

Secondary

MeasureTime frameDescription
Concordance rate2 yearsConcordance 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 yearsRecurrence-free survival (RFS) is defined as the time from date of curative surgery to the time of recurrence or death, whichever comes first.
Overall survival (OS)5 yearsOverall survival (OS) is defined as the time from date of curative surgery to the time of death of any reason.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026