Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University
About this trial
The goal of this nationwide, multicenter observational study is to develop and externally validate multimodal large models that can (1) predict the risk of brain metastases and (2) estimate long-term prognosis in patients with non-small cell lung cancer (NSCLC).
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old;
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.
Disqualifiers
Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
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.
Trial population
Patients are collected all over China
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention
Treatment groups
20,000 Participants
are divided into 2 treatment groupsGroup A: Construction of AI models (retrospective cohort)1 intervention
Group B: Validation of AI models (prospective cohort)1 intervention
Trial outcomes
Primary outcomes
1
The predictive performance of the multimodal large models
Including Sensitivity (SEN), Specificity (SPE), Matthews Correlation Coefficient (MCC), Area Under the Receiver Operating Characteristic Curve (AUC) with its corresponding 95 % confidence interval (CI)
Time frame
2 yearsSecondary outcomes
1
Progression-Free Survival (PFS)
Time frame
2 years2
Intracranial Progression-Free Survival (iPFS)
Time frame
2 years3
Overall Survival (OS)
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: