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A Prospective Observational Cohort Study of Idiopathic Pulmonary Fibrosis and the Development of a Multi-omics Diagnostic Model

A Prospective Observational Cohort Study of Idiopathic Pulmonary Fibrosis and the Development of a Multi-omics Diagnostic Model

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117353
Enrollment
Unknown
Registered
2026-01-22
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Idiopathic Pulmonary Fibrosis, IPF

Interventions

Gold Standard:Pathologically confirmed UIP type
Index test:The UIP-specific diagnostic model that captures the multi-gene, multi-protein signature of the "pathological niche," and develop a dynamic framework for gauging fibrotic activity.

Sponsors

State Key Laboratory of Respiratory Disease, National Clinical Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: a) IPF diagnosis can be definitively established through clinical symptoms, laboratory tests, and imaging findings reviewed by a multidisciplinary team (MDT); b) After MDT discussion, lung biopsy is deemed unnecessary for a conclusive IPF diagnosis; c) Following initial MDT review, histopathological assessment (e.g., SLB or TBLC) is performed and a second MDT conference confirms fulfillment of IPF diagnostic criteria; d) The patient voluntarily enrolls in the study and provides written informed consent.

Exclusion criteria

Exclusion criteria: a) ILD of known alternative etiology (e.g., connective-tissue disease, occupational/environmental exposure, drug toxicity); b) Co-existent severe systemic disorders (e.g., advanced heart failure, end-stage renal disease, active malignancy) with an expected survival <1 year; c) Pregnancy or lactation; d) Inability to provide informed consent or to comply with follow-up procedures; e) Any other condition that, in the investigator’s judgment, renders the participant unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Mortality rate;Significant decline in lung function;Accuracy;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactQun Luo

the First Affiliated Hospital of Guangzhou Medical University, Guangzhou Institute of Respiratory Health

luoqunx@163.com+86 159 1577 7683

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026