Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer

NCT06684418 | Recruiting

• 1 other identifier: OLNM-AI
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC (Non-small Cell Lung Cancer); Artificial Intelligence (AI); Lymphnode Metastasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Overall Survival (OS)

  1 year

Study Arms (2)

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.

Diagnostic Test: chest enhanced CT

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.

Diagnostic Test: chest enhanced CT

Interventions

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.

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Early-stage NSCLC receiving curative treatment (surgery or SBRT).

You may qualify if:

• Pathologically confirmed non-small cell lung cancer;
• Clinical stage I (AJCC, 8th edition, 2017);
• Age≥18 years old;
• KPS score≥70;
• Patients who have undergone primary NSCLC radical surgery or SBRT treatment;
• Complete systemic lesion imaging assessment before primary NSCLC radical surgery or SBRT treatment (Note: Tumor size ≥ 3 cm or centrally located tumor requires PET/CT and/or invasive mediastinal staging);
• Patients willing to cooperate with the follow-up after primary NSCLC radical surgery;
• informed consent of the patient.

You may not qualify if:

• Poor quality of computed tomography imaging;
• Baseline imaging shows pure ground-glass nodules (GGO);
• Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
• Loss to follow-up.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university Shanghai Cancer Center

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhengfei Zhu, PhD

CONTACT

+86-18017312901; fuscczzf@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

CN (1)