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

NCT07190703 | Not Yet Recruiting

• 1 other identifier: DIILD-20250901
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anti-Tumor Drug-Associated Interstitial Pneumonia

Outcome Measures

Primary Outcomes (1)

• Treatment Response Rate

  12 week

Study Arms (4)

Exposed with Drug-induced ILD Group

Treated without ILD Group

Non-cancer ILD Group

Benign Pulmonary Nodule Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fuzhou University Affiliated Provincial Hospital: lead

Central Study Contacts

Xiujuan Yao

CONTACT

+8613950391209; yxj@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share