Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-18 @ 12:22 PM
Study NCT ID:
NCT02798861
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2016-06-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Controlled Attenuation Parameter (CAP) in Liver Allografts
Sponsor:
Andres Duarte-Rojo
Organization:
Study Overview
Official Title:
Usefulness of Controlled Attenuation Parameter (CAP) for the Assessment of Liver Steatosis in Liver Donors
Status:
COMPLETED
Status Verified Date:
2020-07
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:
The primary aim is to determine the accuracy of CAP in the quantification of liver steatosis using liver biopsies as reference. Secondarily, investigators will correlate transient elastography (TE) and CAP results, analyze possible associations between CAP/TE and post-liver transplant (LT) clinical outcomes, and evaluate the change in CAP after LT. The study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.
Detailed Description:
This is a coordinated study utilizing 3 recruitment centers (University of Arkansas for Medical Sciences \[UAMS\], Stanford University, and Mayo Clinic) 2 liver pathology reading centers (University of Michigan and Mayo Clinic), and 1 coordinating center (University of Arkansas). The cohort study with a cross-sectional component for the primary aim has been completed (through independent Institutional Review Board \[IRB\] agreements) at UAMS, Stanford University, and the Mayo Clinic. The samples collected at the three recruitment centers will be sent to the biopsy center at the University of Michigan and Mayo Clinic for evaluation. The Liver Transplant Program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. Criteria for recruitment are as follows:
Inclusion criteria - Liver Recipient
* Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor
* Valid TE with Fibroscan 530, defined as:
* At least 10 valid measurements
* Interquartile Range (IQR)/Median stiffness value \<30% (only in cases with \>7.1 kPa) Exclusion criteria - Liver Recipient
* Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
* Donation after circulatory death (DCD)
* No liver biopsy obtained during organ procurement process
Inclusion criteria - Liver Recipient
* Men and women, Age 18-years old to 80-years old inclusive Inclusion criteria - Liver Donor
* Valid TE with Fibroscan 530, defined as:
* At least 10 valid measurements
* Interquartile Range (IQR)/Median stiffness value \<30% (only in cases with \>7.1 kPa) Exclusion criteria - Liver Recipient
* Patient did not undergo liver transplantation Exclusion criteria - Liver Donor
* Donation after circulatory death (DCD)
* No liver biopsy obtained during organ procurement process
Study Oversight
Has Oversight DMC:
False
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?: