Viewing Study NCT02941003


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Study NCT ID: NCT02941003
Status: UNKNOWN
Last Update Posted: 2016-10-27
First Post: 2016-10-19
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer
Sponsor: Shanghai Chest Hospital
Organization:

Study Overview

Official Title: Establishment and Evaluation for Pathological Diagnostic Criteria of Intraoperative Frozen Section of Early Stage Lung Cancer
Status: UNKNOWN
Status Verified Date: 2016-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: