Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT04494334
Status:
WITHDRAWN
Last Update Posted:
2023-09-15
First Post:
2020-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Airway Absorption Sampling Methods
Sponsor:
Imperial College London
Organization:
Study Overview
Official Title:
Development of Airway Absorption Sampling Methods for Biomarker Assessment in Probable Idiopathic Pulmonary Fibrosis (IPF) Patients
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by funder- terminated before CCC and recruitment- no recruitment and no data collection
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBRO-SAM
Brief Summary:
The study will measure airway inflammation in probable idiopathic pulmonary fibrosis (IPF) and sarcoidosis as well as in healthy volunteers. This can help understand the molecular basis of these diseases, why these diseases happen, and what makes patients develop lung fibrosis. These insights should one day help to monitor patients and aid in their diagnosis and treatment.
Detailed Description:
IPF is a progressive disease caused by irreversible scarring of the lung, and disease trajectory is not easily predicted based on clinical measurements. Biomarkers reflective of molecular pathways involved in IPF may help inform patient trajectory, but have been difficult to identify in circulation due to the disease manifesting in the lung. The study team will measure biomarkers from Probable IPF patients, sarcoidosis patients, and healthy volunteers using novel sampling methods involving absorption of upper and lower airway fluids. These novel sampling methods may enable less invasive and potentially more sensitive methods to detect disease activity and will be performed in IPF and sarcoidosis patients during a routine bronchoscopy procedure. The study team will compare the levels of biomarkers that have been shown to be predictive of disease course in airway fluids of probable IPF patients versus sarcoidosis and healthy controls. This study may help understand the molecular basis of IPF, and improve the understanding of diagnosis and treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 239911 | OTHER | IRAS | View |