- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822911
Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly (Caesar)
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.
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colmar, France, 68000
- Reseau d'Appui aux Generalistes (RAG)
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Mulhouse, France, 68100
- GHRMSA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Alcohol Used Disorders Identification Test (AUDIT C)
Submission 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.
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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.
Other Names:
Blood sample to collect carbohydrate deficient transferrin (CDT) only if the Alcohol Used Disorders Identification Test (AUDIT C) reports at least 1 point.
Other Names:
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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Analysis performed when at least 1 point at the AUDIT-C questionnaire, confirming presence of alcohol consumption
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Within 3 days after enrollment in the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of the disturbance of Gamma-glutamyltranspeptidase when presence of alcohol consumption, with at least 1 point in the AUDIT-C questionnaire
Time Frame: Within 3 days after enrollment in the study
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If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point
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Within 3 days after enrollment in the study
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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
Time Frame: Within 3 days after enrollment in the study
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If collected as routine practice : at the same time as Carbohydrate Deficient Transferrin analysis when Audit-C questionnaire reports at least 1 point
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Within 3 days after enrollment in the study
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Socio-economic characteristics of alcohol abusers : Socioprofessional category
Time Frame: Within 3 days after enrollment in the study
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Classification of professions and socioprofessional categories of the French National institute of Statistics and economics.
9 types of working classes.
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Within 3 days after enrollment in the study
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Socio-economic characteristics of alcohol abusers : Education Category
Time Frame: Within 3 days after enrollment in the study
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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
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Within 3 days after enrollment in the study
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Socio-economic characteristics of alcohol abusers : Way of life
Time Frame: Within 3 days after enrollment in the study
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Description of the patient's environment :
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Within 3 days after enrollment in the study
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Collaborators and Investigators
Investigators
- Principal Investigator: Cecile Schnell, MD, Groupe hospitalier de la région de Mulhouse et Sud Alsace
Publications and helpful links
General Publications
- Henni A, Bideau C, Routon X, Berrut G, Cholet J. [Prevalence and issues of screening for alcohol consumption among elderly inpatients admitted to acute geriatric inpatient unit]. Geriatr Psychol Neuropsychiatr Vieil. 2013 Mar;11(1):33-41. doi: 10.1684/pnv.2013.0397. French.
- Mundle G, Ackermann K, Munkes J, Steinle D, Mann K. Influence of age, alcohol consumption and abstinence on the sensitivity of carbohydrate-deficient transferrin, gamma-glutamyltransferase and mean corpuscular volume. Alcohol Alcohol. 1999 Sep-Oct;34(5):760-6. doi: 10.1093/alcalc/34.5.760.
- Hermansson U, Helander A, Huss A, Brandt L, Ronnberg S. The Alcohol Use Disorders Identification Test (AUDIT) and carbohydrate-deficient transferrin (CDT) in a routine workplace health examination. Alcohol Clin Exp Res. 2000 Feb;24(2):180-7.
- Anton RF, Lieber C, Tabakoff B; CDTect Study Group. Carbohydrate-deficient transferrin and gamma-glutamyltransferase for the detection and monitoring of alcohol use: results from a multisite study. Alcohol Clin Exp Res. 2002 Aug;26(8):1215-22. doi: 10.1097/01.ALC.0000023986.42254.F5.
- Schwan R, Albuisson E, Malet L, Loiseaux MN, Reynaud M, Schellenberg F, Brousse G, Llorca PM. The use of biological laboratory markers in the diagnosis of alcohol misuse: an evidence-based approach. Drug Alcohol Depend. 2004 Jun 11;74(3):273-9. doi: 10.1016/j.drugalcdep.2004.01.002.
- Allen JP, Litten RZ, Anton RF, Cross GM. Carbohydrate-deficient transferrin as a measure of immoderate drinking: remaining issues. Alcohol Clin Exp Res. 1994 Aug;18(4):799-812. doi: 10.1111/j.1530-0277.1994.tb00043.x.
- Bortolotti F, De Paoli G, Tagliaro F. Carbohydrate-deficient transferrin (CDT) as a marker of alcohol abuse: a critical review of the literature 2001-2005. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Sep 1;841(1-2):96-109. doi: 10.1016/j.jchromb.2006.05.005. Epub 2006 May 24.
- Salaspuro M. Carbohydrate-deficient transferrin as compared to other markers of alcoholism: a systematic review. Alcohol. 1999 Nov;19(3):261-71. doi: 10.1016/s0741-8329(99)00044-0.
- WHO Expert Committee on Problems Related to Alcohol Consumption. WHO Expert Committee on Problems Related to Alcohol Consumption. Second report. World Health Organ Tech Rep Ser. 2007;(944):1-53, 55-7, back cover.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 809
- 2016-A00027-44 (Other Identifier: France: Agence Nationale de Sécurité du Médicament et des produits de santé)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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