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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07190703

Enrollment

200

Registered

2025-09-24

Start date

2025-09-30

Completion date

2026-09-30

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Tumor Drug-Associated Interstitial Pneumonia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Treatment Response Rate	12 week

Contacts

Primary ContactXiujuan Yao

yxj@fjmu.edu.cn+8613950391209

Outcome results