Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04363424
Status:
UNKNOWN
Last Update Posted:
2020-04-27
First Post:
2020-04-21
Brief Title:
Alcohol Biomarker Study
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Phenotypical and Pathophysiological Characterization of Patients With Alcohol-related Liver Disease
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
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:
Objective To validate ethyl glucuronide in scalp hair fingernail and urine as a biomarker for alcohol use in patients with alcoholic cirrhosis
Background Alcoholic cirrhosis is a leading indication for liver transplantation in abstinent patients However the assessment of alcohol use remains a daily diagnostic challenge Ethyl glucuronide EtG is the most promising biomarker for the detection of alcohol use EtG can be both a short-term urinary EtG and long-term biomarker scalp hair and nail EtG Although EtG is synthetized in the hepatocyte the validation of these biomarkers and their proposed cut-off values is not present or scarce in patients with cirrhosis impeding their widespread clinical use
Therefore the investigators will assess the diagnostic accuracy of EtG in scalp hair fingernail and urine in a cohort of patients with cirrhosis In addition the investigators will apply a new mass spectrometry imaging MSI method to visualize the distribution of EtG in scalp hair allowing a visual chronological assessment of alcohol intake based on a single hair strand
Methods Blood proximal scalp hair fingernail samples and urine will be collected from patients with alcoholic cirrhosis at the Maastricht University Medical Center Alcohol intake in the previous 3 months will be questioned using the Timeline Followback method The diagnostic accuracy of hair EtG analyzed with matrix-assisted laser desorptionionization-MSI and routine gas chromatography-tandem mass spectrometry GC-MSMS fingernail and urinary EtG both GC-MSMS for moderate and excessive alcohol use will be assessed in a validation cohort Secondly the investigators will assess the diagnostic potential of these EtG biomarkers in a clinical application group of patients with alcoholic cirrhosis undergoing screening for liver transplantation
Anticipated results The combination of different EtG biomarkers allows accurate assessment of abstinence and alcohol use in patients with alcoholic cirrhosis and therefore can be implemented in the daily care of liver patients
Background Alcoholic cirrhosis is a leading indication for liver transplantation in abstinent patients However the assessment of alcohol use remains a daily diagnostic challenge Ethyl glucuronide EtG is the most promising biomarker for the detection of alcohol use EtG can be both a short-term urinary EtG and long-term biomarker scalp hair and nail EtG Although EtG is synthetized in the hepatocyte the validation of these biomarkers and their proposed cut-off values is not present or scarce in patients with cirrhosis impeding their widespread clinical use
Therefore the investigators will assess the diagnostic accuracy of EtG in scalp hair fingernail and urine in a cohort of patients with cirrhosis In addition the investigators will apply a new mass spectrometry imaging MSI method to visualize the distribution of EtG in scalp hair allowing a visual chronological assessment of alcohol intake based on a single hair strand
Methods Blood proximal scalp hair fingernail samples and urine will be collected from patients with alcoholic cirrhosis at the Maastricht University Medical Center Alcohol intake in the previous 3 months will be questioned using the Timeline Followback method The diagnostic accuracy of hair EtG analyzed with matrix-assisted laser desorptionionization-MSI and routine gas chromatography-tandem mass spectrometry GC-MSMS fingernail and urinary EtG both GC-MSMS for moderate and excessive alcohol use will be assessed in a validation cohort Secondly the investigators will assess the diagnostic potential of these EtG biomarkers in a clinical application group of patients with alcoholic cirrhosis undergoing screening for liver transplantation
Anticipated results The combination of different EtG biomarkers allows accurate assessment of abstinence and alcohol use in patients with alcoholic cirrhosis and therefore can be implemented in the daily care of liver patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| METC 19-080 | OTHER | METC | None |