Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer

October 25, 2016 updated by: Jie Zhang, Shanghai Chest Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCT treatment
Randomly assigned patients whose small pulmonary nodules are inflated with the diluted OCT medium (2:3) used for frozen section, and then detected under microscope for their histopathological characteristics, by immunostaining for specific protein expression, by NGS (next-generation sequencing) for driver mutations.
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.
Other Names:
  • Illumina Nexseq500
Experimental: OCT free
Randomly assigned patients whose small pulmonary nodules are uninflated with OCT used for frozen section, and then detected under microscope for their histopathological characteristics, by immunostaining for specific protein expression, by NGS for driver mutations.
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.
Other Names:
  • Illumina Nexseq500

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Investigators

  • Principal Investigator: Jie Zhang, MD, MS., Shanghai Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chest005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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