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This nationwide, multicenter observational study aims to develop and validate a multimodal artificial intelligence (AI) model for detecting occult lymph node metastasis in early-stage non-small cell lung cancer (NSCLC) patients. Despite advances in lymph node staging, 12.9%-39.3% of occult nodal metastasis cases remain undetected preoperatively, affecting treatment decisions. This study will use deep learning to extract imaging features of occult metastasis and combine them with clinical data to build an AI model for risk prediction. This study will provide insights into the feasibility of AI-driven detection of occult metastasis, supporting clinical decision-making and potentially revealing underlying biological mechanisms of lymph node metastasis in NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Cohort | Enrolling about 5,000 early-stage NSCLC patients from January 2018 to June 2024 across 25 centers in China, data including chest CT scans and clinicopathological parameters will be used to train and validate the AI model. Patients will be divided into "high-risk" and "low-risk" groups based on the model's risk score, and clinical benefits of treatments like lymph node dissection, adjuvant therapy, and SBRT will be analyzed. |
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| Prospective Cohort | Enrolling 1,000 patients from November 2024 to October 2025, this cohort will prospectively validate the AI model's performance and explore the biological basis of metastasis by analyzing pathological tissues, RNA sequencing, and tumor immune microenvironment characteristics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chest enhanced CT | Diagnostic Test | This is an observational study and patients will receive routine clinical treatment according to the corresponding guidelines. We will collect the enrolled patient's chest enhanced CT and clinicopathological parameters. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival (RFS) | The time from surgical treatment or SBRT to disease recurrence or death. Patients who were still not progressing at the time of analysis will have the date of their last contact as the cutoff date. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from the surgery or SBRT until death from any cause. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Early-stage NSCLC receiving curative treatment (surgery or SBRT).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengfei Zhu, PhD | Contact | +86-18017312901 | fuscczzf@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan university Shanghai Cancer Center | Recruiting | Shanghai | China |
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50 patients will be selected to analyze the histopathology of the lesions and explore the relevant characteristics. RNA sequencing and multicolor fluorescence staining will be performed to explore differential genes and enriched signaling pathways. The tumor immune microenvironment will also be analyzed.
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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