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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05830812
Other study ID # HXJY20220701
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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