Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Fuzhou University Affiliated Provincial Hospital

Conditions:

Anti-Tumor Drug-Associated Interstitial Pneumonia

Eligibility:

All Genders

18-100 years

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, tran...

Eligibility Criteria

Inclusion

  • 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

  • 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)
  • Prolonged pre-enrollment treatment with moderate-to-high dose systemic corticosteroids or immunosuppressive agents that would compromise baseline evaluation
  • Absolute contraindications to bronchoscopic procedures or inability to comply with scheduled key follow-up assessments
  • Severe decompensated comorbid conditions
  • Pregnancy or lactation period.

Key Trial Info

Start Date :

September 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT07190703

Start Date

September 1 2025

End Date

September 1 2026

Last Update

September 24 2025

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