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

NCT ID: NCT05830812

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Adenocarcinoma, Stage I

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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adenocarcinoma in situ

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

Invasiveness diagnosis

Intervention Type DIAGNOSTIC_TEST

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.

Invasiveness diagnosis

Intervention Type DIAGNOSTIC_TEST

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.

Invasiveness diagnosis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Invasiveness diagnosis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yang Jin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Jin, PHD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xueyun Tan, MD

Role: CONTACT

13419692313 ext. 86

Facility Contacts

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Xueyun Tan, MD

Role: primary

13419692313 ext. 86

Other Identifiers

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HXJY20220701

Identifier Type: -

Identifier Source: org_study_id

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