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

Lung Adenocarcinoma, Stage I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830812
• Other study ID #: HXJY20220701
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Wuhan Union Hospital, China
• Contact: Xueyun Tan, MD
• Phone: 13419692313
• Email: tanxueyun93[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma, Stage I

Intervention

Diagnostic Test:
• Invasiveness diagnosis
To predict the invasiveness of patients with small-sized lung adenocarcinoma intraoperatively based on multi-modal information.

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final pathology diagnosis of the paraffin section stained with HE	The final pathology diagnosis after resection	Immediately after operation