NCT02873663

Brief Summary

The investigators will test the validity of biomarkers for the detection of heavy alcohol use in patients with and without liver disease.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
5.4 years until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

14.7 years

First QC Date

April 13, 2011

Last Update Submit

July 9, 2024

Conditions

Alcohol AbuseLiver Disease

Outcome Measures

Primary Outcomes (1)

  • level of disialotransferrin in blood (expressed as percentage di-sialotransferrin) and ethyl glucuronide (expressed in pg/mg) in hair

    Blood and hair will be collected at one single time-point (procedure of blood and hair sampling takes 30 min) to measure serum CDT and hair ethylglucuronide levels (markers of alcohol use in the prior time period) when the patient presents itself at the hospital, without further follow-up.

    single determination at inclusion (both on the same day, when patient is seen at the outpatient clinic or when admitted to the hospital) without follow-up

Secondary Outcomes (1)

  • influence of the stage of liver and renal impairment on serum CDT and hair EtG

    on the basis of a single determination which is done for the standard care (when patient is seen at the outpatient clinic or when admitted to the hospital)

Study Arms (2)

heavy drinkers

EXPERIMENTAL

Plasma and head hair collection

Procedure: Plasma and head hair collection

teetotalers

EXPERIMENTAL

Plasma and head hair collection

Procedure: Plasma and head hair collection

Interventions

Plasma and head hair collectionPROCEDURE

Plasma and head hair collection

heavy drinkersteetotalers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who do not drink alcohol, moderate drinkers (between 0 and 60 g a day) and patients who drink 60 or more grams alcohol a day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

AlcoholismLiver Diseases

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDigestive System Diseases

Study Officials

  • Jef Verbeek, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2011

First Posted

August 19, 2016

Study Start

December 1, 2010

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

BE(1)