Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-15 @ 2:06 AM
Study NCT ID:
NCT02631720
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2015-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLAD Phenotype Specific Risk Factors and Mechanisms
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
A Prospective Multicenter Observational Cohort Study to Define the Risks Factors, Mechanisms, and Manifestations of Chronic Lung Allograft Dysfunction (CLAD) Phenotypes (CTOT-20)
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
While many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. In this study doctors are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation.
The purpose of this study is to help doctors determine:
* why some people get CLAD and others do not
* how patients who get CLAD do after CLAD is diagnosed
* how CLAD may affect quality of life
The purpose of this study is to help doctors determine:
* why some people get CLAD and others do not
* how patients who get CLAD do after CLAD is diagnosed
* how CLAD may affect quality of life
Detailed Description:
This is an observational, prospective, multicenter study of newly transplanted adult, first lung transplant recipients that will collect longitudinal clinical data, patient reported quality of life (QOL) data, and serial biological samples to determine the risk factors, pathophysiology, and manifestations of restrictive chronic lung allograft dysfunction (RCLAD) and bronchiolitis obliterans syndrome (BOS). Anticipated participant accrual is within three years of study start-up. The total study duration is four years. Participants will be followed a minimum of 1 and a maximum of 4 years.
Study Oversight
Has Oversight DMC:
True
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?: