Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer

Shanghai Jiao Tong University

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: NGS; Device: microscope; Other: immunostaining

Study type: Interventional

Funder types: Other

Identifiers

NCT02941003

Chest005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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540 participants in 2 patient groups

OCT treatment

Experimental group

Description:

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.

Treatment:

Other: immunostaining

Device: microscope

Device: NGS

OCT free

Experimental group

Description:

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.

Treatment:

Other: immunostaining

Device: microscope

Device: NGS