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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia

NCT06192303

Immune Checkpoint Inhibitor Associated Pneumonia

RECRUITING

Multi-omics Detection Techniques for Differentiating Benign and Malignant Pulmonary Nodules

NCT07047573

Lung Cancer (Diagnosis) Pulmonary Nodule Persistent

RECRUITING

Identify Prognostic Biomarkers of Lung Cancer

NCT05010330

Lung Cancer Lung Adenocarcinoma Lung Squamous Cell Carcinoma +1 more

UNKNOWN

Monitoring the Changes of Tumor-related Biomarkers Before and After Pulmonary Nodule Biopsy.

NCT03397355

Lung Cancer

UNKNOWN

Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing

NCT03320044

Carcinoma Non-small-cell Lung Cancer Lung Neoplasm

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anti-Tumor Drug-Associated Interstitial Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exposed with Drug-induced ILD Group

No interventions assigned to this group

Treated without ILD Group

No interventions assigned to this group

Non-cancer ILD Group

No interventions assigned to this group

Benign Pulmonary Nodule Group

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes