Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT07190703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research on Early Diagnosis and Risk Stratification Biomarkers of Anti-Tumor Drug-Associated Interstitial Pneumonia Driven by Multi-Omics Integration
Sponsor:
Fuzhou University Affiliated Provincial Hospital
Organization:
Study Overview
Official Title:
Research on Early Diagnosis and Risk Stratification Biomarkers of Anti-Tumor Drug-Associated Interstitial Pneumonia Driven by Multi-Omics Integration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
This study aims to construct an early diagnostic biomarker panel and risk stratification model for anti-tumor drug-related ILD through integrative analysis of multi-omics data including genomics, transcriptomics, proteomics, and metabolomics. Using baseline and post-treatment longitudinal samples collected from a multi-center prospective cohort, we will apply machine learning to screen for stable and reproducible feature sets and evaluate their sensitivity, specificity, and clinical applicability in an independent validation cohort. The goal is to achieve early identification and stratified management of ILD, optimize treatment decisions, reduce the incidence of severe adverse events, and improve patient survival and quality of life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: