NCT02941003

Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer

Establishment and Evaluation for Pathological Diagnostic Criteria of Intraoperative Frozen Section of Early Stage Lung Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is: 1. To establish a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma, including clinicopathologic and molecular characteristics. 2. To assess its clinical usefulness in guiding surgical procedure for early stage lung adenocarcinoma.

Detailed description

The detection rate of small pulmonary nodules is increasing due to the widespread use of high-resolution computed tomography (CT) screening in clinical practice. These minute pulmonary nodules are suggestive of atypical adenomatous hyperplasia (AHH), adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), and invasive adenocarcinoma. Hence, the precision diagnosis of intraoperative frozen section is particularly imperative for its fundamental role in assess indeterminate lung lesions and guide the extent of subsequent surgical procedure. However, it is still difficult for the surgical pathologist to apply the various features according to the newly revised WHO classification of lung adenocarcinoma (2015) to guide surgical management due to their unascertained accuracy or heterogeneity of lung cancer or technique problem. Therefore, the establishment and assessment for a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma are our primary aim in this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	microscope	Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .
OTHER	immunostaining	Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .
DEVICE	NGS	The investigators used the device to detect the gene mutations of OCT treatment or OCT free samples obtained from part of the patients.

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-12-01
• Completion: 2019-10-01
• First posted: 2016-10-21
• Last updated: 2016-10-27

Locations

1 site across 1 country: China