Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-28 @ 2:04 PM
Study NCT ID:
NCT03697395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-18
First Post:
2018-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
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:
Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue in patients after lung transplant. This study is a registry-forming study with concurrent tissue banking from surveillance bronchoscopy in addition to extra tissue sampling of blood and urine. Patients will be characterized by usual clinical phenotyping and the latest imaging methods so that diseased condition underlying CLAD can be better understood.
Detailed Description:
Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue that lead to almost 50% mortality within 5 years from the time of lung transplant. In the past CLAD was exclusively occurring in small airways causing a condition called "Bronchiolitis Obliteran Syndrome" (BOS). However, recently many have observed restrictive changes in lung physiology with or without parenchymal abnormalities. This new CLAD is called RAS or RCLAD. What is also concerning is that RAS is thought to be associated with disproportionally high morbidity and mortality. This clinical trial intends to create a registry of patients who completed lung transplant and who are undergoing routine surveillance bronchoscopy. A subgroup of patients will be characterized by hyper polarized gas magnetic resonance image to enhance detection of CLAD, and to be correlated between the MRI imaging results and clinical/biochemical results. This study is anticipated to advance our understanding of CLAD which is currently inevitably fatal outcome among patients after lung transplant.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Ithriv | OTHER | National Institute of Health | View |