AzTrials
AzTrials

Alcohol AbuseCaesarNCT02822911

Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly

A study testing Alcohol Used Disorders Identification Test (AUDIT C), Carbohydrate deficient transferrin and Gamma glutamyl transpeptidase in people with Alcohol Abuse, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Alcohol misuse affects 5 million people in France. Even though the elderly are also concerned by this pathology, there is not much information about chronic alcohol misuse of this population in particular. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Alcohol Abuse
What is being tested?
Alcohol Used Disorders Identification Test (AUDIT C), Carbohydrate deficient transferrin and Gamma glutamyl transpeptidase
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
2 sitesFrance
Study dates
Mar 2016to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 60 years old
  • Patients hospitalized for a day or more in the Geriatrics Department of Mulhouse, GHRMSA :
  • Coming from home within 48 hours after admission to the GHRMSA
  • Study procedures performed within 72 hours after admission to the GHRMSA
  • Or new members of the General Practitioner Support Association of Alsace, France (translated in French as the "RAG") living in Mulhouse, Thann and Saint Louis cities (France) :
  • Living at home and joining the RAG between the 1st of March and the 31st of October 2016
Show all 9Show fewer
  • Study Procedures performed within 3 days after enrollment in the study
  • Relative or helper available who usually visits the patient at home at least once a week
  • Absence of alcoholic excipient in the concomitant medication

Who cannot join

  • Age < 60 years old
  • Admitted in the Geriatrics Department of Mulhouse after more than 48hours after admission to the GHRMSA
  • Presence of the following symptoms :
  • Hepatobiliary deficiency related to a primary biliary cirrhosis
  • Autoimmune or viral cirrhosis
  • Hepatocellular carcinoma
Show all 10Show fewer
  • Congenital metabolic disorder in protein glycosylation
  • Known genetics variance in Tf B or D transferrin
  • Living in an elderly care institution
  • Already enrolled in this study

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Reseau d'Appui aux Generalistes (RAG)

    Colmar, 68000

  • GHRMSA

    Mulhouse, 68100

Other trials in France

About this study

Official title: Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly. A French Multicentered Prospective Interventional Study.

Alcohol misuse affects 5 million people in France. Even though the elderly are also concerned by this pathology, there is not much information about chronic alcohol misuse of this population in particular.

Biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a biological marker of alcohol misuse, the specificity of the CDT is known to be superior to the GGT as well.

Read more

However, when it comes to the elderly, alcoholism diagnosis tools are based on research of younger populations.

This study aims to evaluate the benefit of the CDT to detect chronic alcohol use in the elderly.

Read the detailed description

Problematic alcohol misuse is frequent but tends to decrease with age. According to the French Alcohology Society, 10% of the adult population is alcohol abstinent and after 65 years old, they are 40% to abstain from alcohol.

On the other hand, the French Alcohology Society also reports that a regular or daily alcohol consumption for older people increases the risk of dependence on alcohol.

For the elderly, biological disorders can be related to polymedication or other conditions related to the aging process, making it difficult to diagnose alcoholism for aged people.

For the study, the three-item Alcohol Use Disorders Identification Test (AUDIT-C) will be submitted to :

  • every patient admitted in the Hospital of Mulhouse (France) for at least a day in the Geriatrics Department
  • every patient entering the General Practitioner Support Association of Alsace, France (translated in French as the "RAG").

When the score of the AUDIT-C reaches at least 1 point, the study will collect results of the GGT and MCV performed as routine practice and add the CDT in the blood tests.

Conditions
Alcohol Abuse
Being tested
Alcohol Used Disorders Identification Test (AUDIT C), Carbohydrate deficient transferrin, Gamma glutamyl transpeptidase, Mean Corpuscular Volume
Keywords
elderly, chronic alcoholism, Carbohydrate Deficient Transferrin, Biological Detection / Diagnosis
Medical subject headings
Alcoholism, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alcohol Used Disorders Identification Test (AUDIT C)Behavioural

    Also called Audit-C questionnaire

    The Audit-C questionnaire is a three item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol abuse disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument.

    Score from 0 to 12. Each Audit-C question has a 5 answer choice, allotted points are from 0 to 4 points. In men, a score of 4 is considered as positive, optimal for identifying hazardous users or active alcohol abuse disorders. The same for 3 points in women.

  • Carbohydrate deficient transferrinProcedure or surgery

    Also called CDT

    Blood sample to collect carbohydrate deficient transferrin (CDT) only if the Alcohol Used Disorders Identification Test (AUDIT C) reports at least 1 point.

  • Gamma glutamyl transpeptidaseProcedure or surgery

    Also called GGT

    Results of Gamma glutamyl transpeptidase (GGT) performed as routine practice collected only if the Alcohol Used Disorders Identification Test (AUDIT C) reaches at least 1 point.

  • Mean Corpuscular VolumeProcedure or surgery

    Also called MCV

    Results of Mean Corpuscular Volume (MCV) performed as routine practice collected only if the Alcohol Used Disorders Identification Test (AUDIT C) reports at least 1 point.

Study groups in NCT02822911
Study groupRoleWhat they receive
Alcohol Used Disorders Identification Test (AUDIT C)OtherSubmission of Audit-C questionnaire to all the patients of the study. When the result to the AUDIT-C questionnaire reaches at least 1 point, the analysis of the Carbohydrate deficient transferrin (CDT) is performed within 3 days after the beginning of the study. Results of Gamma glutamyl transpeptidase (GGT) and Mean Corpuscular Volume (MCV) performed as routine practice collected at the same time as the CDT analysis.
Receives: Behavioral: Alcohol Used Disorders Identification Test (AUDIT C); Procedure: Carbohydrate deficient transferrin; Procedure: Gamma glutamyl transpeptidase; Procedure: Mean Corpuscular Volume

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Benefit of Carbohydrate Deficient Transferrin to detect chronic alcohol abuse in the elderly compared to usual clinical detection tools

    Analysis performed when at least 1 point at the AUDIT-C questionnaire, confirming presence of alcohol consumption

    Measured: Within 3 days after enrollment in the study

Secondary outcomes (5)

  1. Sensitivity and specificity of the disturbance of Gamma-glutamyltranspeptidase when presence of alcohol consumption, with at least 1 point in the AUDIT-C questionnaire

    If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point

    Measured: Within 3 days after enrollment in the study

  2. Sensitivity and specificity of the disturbance of Mean Corpuscular Volume when presence of alcohol consumption, with at least 1 point in the AUDIT-C questionnaire

    If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point

    Measured: Within 3 days after enrollment in the study

  3. Socio-economic characteristics of alcohol abusers : Socioprofessional category

    Classification of professions and socioprofessional categories of the French National institute of Statistics and economics. 9 types of working classes.

    Measured: Within 3 days after enrollment in the study

  4. Socio-economic characteristics of alcohol abusers : Education Category

    6 levels of education type, from no degree or 9th grade, to Doctor of Philosophy (PhD). Classification created by the French National institute of Statistics and economics

    Measured: Within 3 days after enrollment in the study

  5. Socio-economic characteristics of alcohol abusers : Way of life

    Description of the patient's environment :

    • married or not
    • living alone or not
    • professional help provided at home by either a nurse, or cleaning lady, or meal delivery, or senior helper

    Measured: Within 3 days after enrollment in the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02822911
Sponsor's protocol ID
GHRMSA 809
Other IDs
2016-A00027-44
Acronym
Caesar
Status last verified
Nov 2016
First submitted
30 Jun 2016
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Schnell C (2016) Benefit of carbohydrate deficient transferrin in detecting chronic alcohol abuse in the elderly: study protocol for a multicentre, non-randomized, open-label study. Clin Transl Degener Dis 1(3):121-126.

Questions about this trial

What is this clinical trial studying?

A study testing Alcohol Used Disorders Identification Test (AUDIT C), Carbohydrate deficient transferrin and Gamma glutamyl transpeptidase in people with Alcohol Abuse, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Benefit of Carbohydrate Deficient Transferrin to detect chronic alcohol abuse in the elderly compared to usual clinical detection tools (time frame: Within 3 days after enrollment in the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02822911, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in