Clinical trial NCT02941003: Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer
Official title: Establishment and Evaluation for Pathological Diagnostic Criteria of Intraoperative Frozen Section of Early Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Early stage lung adenocarcinoma
Intraoperative frozen section
Diagnostic criteria
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 540
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of histopathological characteristics between intraoperative frozen section and paraffin section for patients with early stage lung adenocarcinoma
timeFrame: 6 months
Secondary outcomes:
measure: Detection of CD31/CD34, D2-40, Ki67 and p53 among different subtypes of early stage lung adenocarcinoma by immunohistochemical (IHC) analysis
timeFrame: 6 months
measure: Comparison of mutation profiles among different subtypes of early stage lung adenocarcinoma by tissue microdissection and subsequent next generation sequencing (NGS)
timeFrame: 6 months
measure: Verification of the driver mutations from NGS results using droplet digital PCR (ddPCR) in early stage lung adenocarcinoma.
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jie Zhang, MD, MS.
role: PRINCIPAL_INVESTIGATOR
References: