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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed with Drug-induced ILD Group | |||
| Treated without ILD Group | |||
| Non-cancer ILD Group | |||
| Benign Pulmonary Nodule Group |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Response Rate | 12 week |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes four categories of subjects: patients with drug-induced interstitial lung disease (ED group), patients without ILD during treatment (TN group), patients with non-cancer interstitial lung disease (NC-ILD group), and healthy volunteers with benign pulmonary nodules (BPN group).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiujuan Yao | Contact | +8613950391209 | yxj@fjmu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2025 | Sep 17, 2025 |
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| ICF_000.pdf |