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Observational Study for Predicting Pulmonary Fibrosis Worsening

This study is looking at whether a special score, called Single Time Point Prediction (STP), can help doctors predict earlier if your pulmonary fibrosis (a lung disease that causes scarring) will get worse. The STP score uses information from your HRCT scan (a detailed X-ray of your lungs) and artificial intelligence (AI) to look at patterns in your lungs. The study will compare people with different STP scores to see if those with higher scores are more likely to have their disease progress. This study is for people aged 40 or older who have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last five years, have no history of lung transplant, and meet certain lung function requirements. The main goal is to see if the STP score can help identify people who might benefit from anti-fibrotic treatments sooner. This is an observational study, meaning it will not change your current medical care.

Study design
This is an observational study planning to enroll 200 participants. It will group participants into two arms based on their baseline HRCT scan and STP score.
What's involved
The study will collect clinical information such as pulmonary function tests (PFT), symptom scores, 6-minute walk tests (6MWT), and radiologic information from HRCT scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of randomization until the date of first documented progression or death, for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06162884

Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis

Recruiting
Not specifiedAges 18+Observational
University of California, Los Angeles
~200 participants
Updated 2026-06-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) between the two arms by Single Time point Prediction (STP) score
Measured over From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Conditions

Pulmonary Fibrosis

Explore related trials

Idiopathic Pulmonary FibrosisInterstitial Lung Disease

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Samuel Weigt, MD · PRINCIPAL_INVESTIGATOR · UCLA Division of Pulmonary, Critical Care, and Hospitals
  • Jonathan Goldin, MD · PRINCIPAL_INVESTIGATOR · Radiological Sciences at the University of California, Los Angeles

Who to contact

Grace Hyun Kim, PhD
[email protected]
(310) 481-7594
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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 by visual assessment: (1) estimating visually \>5% in whole lung, or (2) mild pulmonary fibrosis and \<5% in whole lung (i.e., early non-IPF-ILD identified by a pulmonologist).
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).
lung transplant after baseline or death
withdraw of consent or transition to another care center

What this trial measures

  • Progression Free Survival (PFS) between the two arms by Single Time point Prediction (STP) scoreFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

    PFS of IPF and non-IPF ILD will be compared in patients with STP \>=30% or \<30%. A higher STP score, ranging from 0% to 100%, indicates a worse outcome. Progression is uniformly defined in both IPF and non-IPF ILD population as the reduction of FVC \>=10% or the reduction of DLCO \>=15% or death due to the disease.