Improving the Intraoperative Diagnosis Accuracy of Invasiveness for Small-sized Lung Adenocarcinoma

Sponsor

Wuhan Union Hospital, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT05830812

Collaborator

(none)

3,000

Enrollment

Location

Anticipated Duration (Months)

62.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to improve the intraoperative diagnosis accuracy of invasiveness for small-sized lung adenocarcinoma by combining multi-modal information. The main question it aims to answer is whether multi-modal information have great value of prediction on the invasiveness for small-sized lung adenocarcinoma. Since a promising limited resection is largely based on intraoperative frozen section diagnosis, there is a growing demand on the high-accuracy of timely pathology diagnosis. The multi-modal information of participants will be collected retrospectively.

Condition or Disease	Intervention/Treatment	Phase
Lung Adenocarcinoma, Stage I	Diagnostic Test: Invasiveness diagnosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Improving the Intraoperative Diagnosis Accuracy for Pre-invasive and Invasive Small-sized Lung Adenocarcinoma Node by Combining Multi-modal Information

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
adenocarcinoma in situ Adenocarcinoma in situ is defined as a small (≤3 cm) localized nodule with lepidic growth, mostly non-mucinous.	Diagnostic Test: Invasiveness diagnosis To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.
minimally invasive adenocarcinoma Minimally invasive adenocarcinoma defined as a small (≤3 cm) solitary adenocarcinoma with a predominantly lepidic pattern and ≤5 mm invasion in greatest dimension.	Diagnostic Test: Invasiveness diagnosis To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.
invasive adenocarcinoma Invasive adenocarcinoma is a malignant epithelial tumor with glandular differentiation, mucin production, or pneumocyte marker expression. The tumors show an acinar, papillary, micropapillary, lepidic, or solid growth pattern, with either mucin or pneumocyte marker expression. The invasive ademocarcinoma component should be present in at least one focus measuring >5mm in greatest dimension.	Diagnostic Test: Invasiveness diagnosis To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.

Arm

Intervention/Treatment

adenocarcinoma in situ

Adenocarcinoma in situ is defined as a small (≤3 cm) localized nodule with lepidic growth, mostly non-mucinous.

Diagnostic Test: Invasiveness diagnosis

To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.

minimally invasive adenocarcinoma

Minimally invasive adenocarcinoma defined as a small (≤3 cm) solitary adenocarcinoma with a predominantly lepidic pattern and ≤5 mm invasion in greatest dimension.

Diagnostic Test: Invasiveness diagnosis

To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.

invasive adenocarcinoma

Invasive adenocarcinoma is a malignant epithelial tumor with glandular differentiation, mucin production, or pneumocyte marker expression. The tumors show an acinar, papillary, micropapillary, lepidic, or solid growth pattern, with either mucin or pneumocyte marker expression. The invasive ademocarcinoma component should be present in at least one focus measuring >5mm in greatest dimension.

Diagnostic Test: Invasiveness diagnosis

To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.

Outcome Measures

Primary Outcome Measures

Final pathology diagnosis of the paraffin section stained with HE [Immediately after operation]
The final pathology diagnosis after resection

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CT examination within 3 months before surgery Patients with operable clinical stage I lung cancer No previous treatment in the lungs or any other organ

≥ 20 years and ≤ 80 years old Tumor less than 3cm in diameter on thin-slice (0.625-1 mm) CT images Lung adenocarcinoma confirmed by surgical resection and histopathological diagnosis

Exclusion Criteria:

Marked artifacts on CT images History of preoperative treatment Incomplete clinical information or DICOM images History of other malignant tumors Lung cancer associated with cystic airspaces