Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521125
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Clinical Genetics and Screening for Idiopathic Pulmonary Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Genetics and Screening for Idiopathic Pulmonary Fibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
GENESI
Brief Summary:
Background
Idiopathic pulmonary fibrosis IPF is the most common and severe form of interstitial lung disease Between 2 and 20 of patients with IPF have a family history of the disease which is considered the strongest risk factor Therefore genetic testing has been increasingly considered as a potential tool to identify patients at risk of developing IPF
According to some studies genetic testing particularly of MUC5B and TERT mutations could be useful to rapidly identify unidentified andor asymptomatic individuals in families as well as in the general population who have interstitial lung anomalies ILA that may indicate a initial stage of pulmonary fibrosis Finding efficient screening methods and associated targeted treatments for IPF may be essential to improving the prognosis and quality of life of those suffering from this disease
Objectives of the study
The study involves two populations of study subjects
patients with FPF and sporadic IPF
first-degree relatives of patients with FPF and sporadic IPF biological relatives not spouses
The primary objective is to determine the prevalence rates of interstitial lung abnormalities in at-risk relatives of patient with IPF and FPF
Study design
Multicenter cross-sectional study without drug and without device conducted in two major Italian tertiary referral hospitals
The entire project is expected to last 24 months
Idiopathic pulmonary fibrosis IPF is the most common and severe form of interstitial lung disease Between 2 and 20 of patients with IPF have a family history of the disease which is considered the strongest risk factor Therefore genetic testing has been increasingly considered as a potential tool to identify patients at risk of developing IPF
According to some studies genetic testing particularly of MUC5B and TERT mutations could be useful to rapidly identify unidentified andor asymptomatic individuals in families as well as in the general population who have interstitial lung anomalies ILA that may indicate a initial stage of pulmonary fibrosis Finding efficient screening methods and associated targeted treatments for IPF may be essential to improving the prognosis and quality of life of those suffering from this disease
Objectives of the study
The study involves two populations of study subjects
patients with FPF and sporadic IPF
first-degree relatives of patients with FPF and sporadic IPF biological relatives not spouses
The primary objective is to determine the prevalence rates of interstitial lung abnormalities in at-risk relatives of patient with IPF and FPF
Study design
Multicenter cross-sectional study without drug and without device conducted in two major Italian tertiary referral hospitals
The entire project is expected to last 24 months
Detailed Description:
None
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