Intraoperative Frozen Section Pathology to Guide Surgical Treatment for Lung Adenocarcinoma (ECTOP-1016)

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05794724

Enrollment

1063

Registered

2023-04-03

Start date

2022-01-01

Completion date

2023-12-31

Last updated

2023-07-24

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-1016). 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.

Countries

China

Contacts

Primary ContactYue Zhao, M.D., Ph.D.

yuezhao97@outlook.com+86 18801735510

Outcome results

None listed

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