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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02941003

Enrollment

540

Registered

2016-10-21

Start date

2016-02-29

Completion date

2019-10-31

Last updated

2016-10-27

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

Conditions

Lung Cancer

Keywords

Early stage lung adenocarcinoma, Intraoperative frozen section, Diagnostic criteria

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.

Interventions

DEVICEmicroscope

Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .

OTHERimmunostaining

Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .

DEVICENGS

The investigators used the device to detect the gene mutations of OCT treatment or OCT free samples obtained from part of the patients.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Patients with suspected pulmonary nodules (5\ 20 mm) by chest CT scan; 2. Patients received surgical operation.

Exclusion criteria

1. Patients compliance is poor and cannot accept follow-up; 2. Patients nursing or pregnant; 3. Patients with a history of any cancer; 4. Patients with confirmed pathological diagnosis or received radiotherapy or chemotherapy or target therapy preoperatively.

Design outcomes

Primary

Measure	Time frame
Comparison of histopathological characteristics between intraoperative frozen section and paraffin section for patients with early stage lung adenocarcinoma	6 months

Secondary

Measure	Time frame
Detection of CD31/CD34, D2-40, Ki67 and p53 among different subtypes of early stage lung adenocarcinoma by immunohistochemical (IHC) analysis	6 months
Comparison of mutation profiles among different subtypes of early stage lung adenocarcinoma by tissue microdissection and subsequent next generation sequencing (NGS)	6 months
Verification of the driver mutations from NGS results using droplet digital PCR (ddPCR) in early stage lung adenocarcinoma.	3 months

Countries

China

Contacts

Primary ContactJie Zhang, MD, MS

18017321572@163.com(+86)18017321572

Backup ContactKeke Yu, MD, PhD

ykkxx@shchest.org(+86)18930859590

Outcome results

None listed

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