Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer
NCT ID: NCT07107035
Last Updated: 2025-08-06
Study Results
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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NOT_YET_RECRUITING
20000 participants
OBSERVATIONAL
2025-09-30
2030-07-31
Brief Summary
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The main questions it aims to answer are:
* Can a multimodal large model that fuses imaging, pathology, genomic, and clinical data accurately identify NSCLC patients at high risk of developing brain metastases?
* Can a multimodal large model reliably forecast intracranial progression-free survival, progression-free survival, and overall survival across diverse real-world treatment settings? (ie, patients receiving distinct treatment regimens, in different treatment lines and with or without intracranial local therapies).
Because this is an observational study, there are no investigational treatments; instead, researchers will compare outcomes among patients who receive standard-of-care therapies (surgery, radiotherapy, systemic therapy) to determine how well the model's predictions align with observed events.
Participants will:
* Allow use of their routinely collected clinical information, imaging (chest CT, brain MRI), pathology slides, and molecular test results for model training and validation
* Undergo standard-of-care follow-ups
* Complete optional quality-of-life questionnaires during scheduled visits
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Construction of AI models (retrospective cohort)
No Intervention: Observational Cohort
No intervention
Validation of AI models (prospective cohort)
No Intervention: Observational Cohort
No intervention
Interventions
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No Intervention: Observational Cohort
No intervention
Eligibility Criteria
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Inclusion Criteria
* KPS score≥70;
* Pathologically confirmed lung cancer;
* Receiving guideline-concordant standard-of-care therapy, defined as: radical surgical resection for early- to mid-stage non-small cell lung cancer (NSCLC); stereotactic radiotherapy for early-stage NSCLC deemed medically inoperable; radical chemoradiotherapy for locally advanced NSCLC; or systemic therapy for advanced-stage NSCLC.
* Complete systemic imaging before treatment initiation, including contrast-enhanced brain MRI and contrast-enhanced chest CT;
* Informed consent of the patient.
Exclusion Criteria
* 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;
* Physical examination findings, clinical laboratory abnormalities, or other uncontrolled medical conditions identified by the investigator as potentially interfering with study results interpretation or increasing the patient's risk of treatment complications
* Pregnant or lactating women.
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhengfei Zhu
Professor
Central Contacts
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Other Identifiers
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LCBM-AI
Identifier Type: -
Identifier Source: org_study_id
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