Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 7:21 AM
Study NCT ID:
NCT07107035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
Multimodal Large Model-Driven Risk and Prognosis Assessment for Brain Metastases in Lung Cancer: A Nationwide, Multicenter, Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: