Research on Early Diagnosis and Risk Stratification Biomarkers of Anti-Tumor Drug-Associated Interstitial Pneumonia Driven by Multi-Omics Integration

Fuzhou University Affiliated Provincial Hospital

Status: Not yet enrolling

Conditions: Anti-Tumor Drug-Associated Interstitial Pneumonia

Study type: Observational

Funder types: Other

Identifiers

NCT07190703

DIILD-20250901

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥18 years of age with the ability to independently provide written informed consent, fulfilling the criteria for either the oncology or control cohort, capable of undergoing baseline BALF and peripheral blood sampling at treatment commencement or time of diagnosis, and consenting to serial blood sampling at 2-4 weeks and 8-12 weeks following treatment initiation.

Exclusion criteria

1. Active infection or established non-drug-related etiology of ILD (including but not limited to connective tissue disease-associated ILD, environmental or occupational exposure-induced ILD, active radiation pneumonitis)
2. Prolonged pre-enrollment treatment with moderate-to-high dose systemic corticosteroids or immunosuppressive agents that would compromise baseline evaluation
3. Absolute contraindications to bronchoscopic procedures or inability to comply with scheduled key follow-up assessments
4. Severe decompensated comorbid conditions
5. Pregnancy or lactation period.

Trial design

200 participants in 4 patient groups

Exposed with Drug-induced ILD Group

Treated without ILD Group

Non-cancer ILD Group

Benign Pulmonary Nodule Group