Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02941003
• Other study ID #: Chest005
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: October 25, 2016
• Start date: February 2016
• Est. completion date: October 2019

Study information

• Verified date: October 2016
• Source: Shanghai Chest Hospital
• Contact: Jie Zhang, MD, MS
• Phone: (+86)18017321572
• Email: 18017321572[@]163.com
• Is FDA regulated: No
• Health authority: China: Shanghai Hospital Development Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: October 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of histopathological characteristics between intraoperative frozen section and paraffin section for patients with early stage lung adenocarcinoma		6 months	No
Secondary	Detection of CD31/CD34, D2-40, Ki67 and p53 among different subtypes of early stage lung adenocarcinoma by immunohistochemical (IHC) analysis		6 months	No
Secondary	Comparison of mutation profiles among different subtypes of early stage lung adenocarcinoma by tissue microdissection and subsequent next generation sequencing (NGS)		6 months	No
Secondary	Verification of the driver mutations from NGS results using droplet digital PCR (ddPCR) in early stage lung adenocarcinoma.		3 months	No