Status:
RECRUITING
Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Brief Summary
This study is a prospective observational study for subjects with idiopathic pulmonary fibrosis (IPF) or non-IPF interstitial lung diseases (ILD). The purpose of this study is to compare whether imag...
Detailed Description
Primary objective is to predict early for progression in both IPF and non-IPF ILD population using an artificial intelligence (AI)/Machine Learning (ML) algorithm of STP score. The primary interest is...
Eligibility Criteria
Inclusion
- IPF
- Established a diagnosis (within 5 years) of IPF by enrolling center as defined by ATS/ERS/JRS/ALAT criteria
- Age over or equal to 40 years old
- No history of lung transplant
- FVC % predicted \>= 45%
- DLCO % predicted \>=25%
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.
- Non-IPF ILD
- Established a diagnosis (within 5 years) of non-IPF ILD by enrolling center.
- Age over or equal to 18 years old
- Presence of chronic fibrosis ILD defined as architectural distortions with reticulation and the presence of traction bronchiectasis estimating visually \>5% in whole lung.
- Patients treated with immunosuppressive agents (other than corticosteroids) for an underlying systemic disease need to be on a stable treatment for at least 12 weeks prior to screening
- FVC % predicted \>= 45%
- DLCO % predicted \>=25%
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method
Exclusion
- Planned to participate in an intervention trial within the next 6 months
- Currently listed for lung transplantation at the time of enrollment
- Malignancy, treated or untreated, other than malignancy unlikely to affect prognosis in the next 3 years such as skin cancer or non-metastatic prostate cancer within the past 5 years
- Any clinically significant co-morbidity, which in the view of investigator, is likely to contribute to mortality or ability to perform PFT's in the next 2 years
- Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) \<0.7 at as screening
- Exclusion of co-morbidities: congestive heart failure (stroke, deep vein thrombosis, pulmonary embolism, myocardial infarction), current virus-associated community acquired pneumonia, smoking-related chronic obstructive lung disease with FEV1 \<70%, history of lung cancer, history of other cancer treated within the past 4 years for IPF and 5 years for non-IPF ILD (excluding basal cell carcinoma of skin).
- HRCT data from subjects with combined pulmonary fibrosis and emphysema (CPFE) can be collected.
- Major Discontinuing Criteria in this study
- lung transplant after baseline or death
- withdraw of consent or transition to another care center
Key Trial Info
Start Date :
November 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 19 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06162884
Start Date
November 6 2024
End Date
August 19 2028
Last Update
June 15 2025
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90024