Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer
NCT ID: NCT02941003
Last Updated: 2016-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
540 participants
INTERVENTIONAL
2016-02-29
2019-10-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
DIAGNOSTIC
SINGLE
Study Groups
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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.
microscope
Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .
immunostaining
Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .
NGS
The investigators used the device to detect the gene mutations of OCT treatment or OCT free samples obtained from part of the patients.
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.
microscope
Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .
immunostaining
Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .
NGS
The investigators used the device to detect the gene mutations of OCT treatment or OCT free samples obtained from part of the patients.
Interventions
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microscope
Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .
immunostaining
Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients received surgical operation.
Exclusion Criteria
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.
40 Years
70 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Jie Zhang
Chief Physician
Principal Investigators
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Jie Zhang, MD, MS.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jie Zhang, MD, MS
Role: primary
Keke Yu, MD, PhD
Role: backup
Other Identifiers
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Chest005
Identifier Type: -
Identifier Source: org_study_id