Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644144
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
P4O2 ILD Extension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Identification of Progressive Pulmonary Fibrosis Precision Medicine for More Oxygen - ILD Extension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P4O2-ILD
Brief Summary:
The goal of this observational study is to identify early biomarkers that can predict the development of progressive pulmonary fibrosis PPF in participants with interstitial lung diseases ILDs The participant population includes adults diagnosed with idiopathic pulmonary fibrosis IPF familial pulmonary fibrosis FPF other fibrotic ILDs and interstitial lung abnormalities ILA
The main questions it aims to answer are
What biomarkers and risk factors are linked to fibrosis progression or can predict rapid worsening and sudden flare-ups in IPF and FPF patients
What biomarkers and risk factors can predict the development of a PPF phenotype in different types of ILD
What biomarkers and risk factors can help identify ILA patients who may develop significant ILD
What biomarkers and risk factors can predict how well ILD patients will respond to treatment
Researchers will compare the outcomes between participants diagnosed with IPFFPF other fibrotic ILDs and ILA to see if early detection biomarkers differ among these groups
Participants will
Undergo blood sampling
Perform lung function tests
Have CT scans
Perform breath analysis
Participate in exposome and microbiome analyses
Complete questionnaires
A subgroup of participants will be offered bronchoscopy
The main questions it aims to answer are
What biomarkers and risk factors are linked to fibrosis progression or can predict rapid worsening and sudden flare-ups in IPF and FPF patients
What biomarkers and risk factors can predict the development of a PPF phenotype in different types of ILD
What biomarkers and risk factors can help identify ILA patients who may develop significant ILD
What biomarkers and risk factors can predict how well ILD patients will respond to treatment
Researchers will compare the outcomes between participants diagnosed with IPFFPF other fibrotic ILDs and ILA to see if early detection biomarkers differ among these groups
Participants will
Undergo blood sampling
Perform lung function tests
Have CT scans
Perform breath analysis
Participate in exposome and microbiome analyses
Complete questionnaires
A subgroup of participants will be offered bronchoscopy
Detailed Description:
Included participants will complete several study visits to collect clinical data and biological samples Study visits will be performed at baseline 3 6 12 24 36 48 and 60 months with a 2-month time window for follow-up visits These time points are aligned with the standard clinical follow-up visits outlined in the ILD Care Path Protocol of Amsterdam UMC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None