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

Primary Purpose

Alcohol Abuse

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Alcohol Used Disorders Identification Test (AUDIT C)

Carbohydrate deficient transferrin

Gamma glutamyl transpeptidase

Mean Corpuscular Volume

About this trial

This is an interventional diagnostic trial for Alcohol Abuse focused on measuring elderly, chronic alcoholism, Carbohydrate Deficient Transferrin, Biological Detection / Diagnosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Reseau d'Appui aux Generalistes (RAG)
GHRMSA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Alcohol Used Disorders Identification Test (AUDIT C)

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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.

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

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

Full Information

NCT ID

NCT02822911

First Posted

June 30, 2016

Last Updated

November 23, 2016

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

1. Study Identification

Unique Protocol Identification Number

NCT02822911

Brief Title

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

Acronym

Caesar

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Abuse

Keywords

elderly, chronic alcoholism, Carbohydrate Deficient Transferrin, Biological Detection / Diagnosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alcohol Used Disorders Identification Test (AUDIT C)

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Alcohol Used Disorders Identification Test (AUDIT C)

Other Intervention Name(s)

Audit-C questionnaire

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Carbohydrate deficient transferrin

Other Intervention Name(s)

CDT

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Gamma glutamyl transpeptidase

Other Intervention Name(s)

GGT

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Mean Corpuscular Volume

Other Intervention Name(s)

MCV

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Within 3 days after enrollment in the study

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Within 3 days after enrollment in the study

Title

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

Description

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

Time Frame

Within 3 days after enrollment in the study

Title

Socio-economic characteristics of alcohol abusers : Socioprofessional category

Description

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

Time Frame

Within 3 days after enrollment in the study

Title

Socio-economic characteristics of alcohol abusers : Education Category

Description

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

Time Frame

Within 3 days after enrollment in the study

Title

Socio-economic characteristics of alcohol abusers : Way of life

Description

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

Time Frame

Within 3 days after enrollment in the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cecile Schnell, MD

Organizational Affiliation

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Official's Role

Principal Investigator

Facility Information:

Facility Name

Reseau d'Appui aux Generalistes (RAG)

City

Colmar

ZIP/Postal Code

68000

Country

France

Facility Name

GHRMSA

City

Mulhouse

ZIP/Postal Code

68100

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23508317

Citation

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.

Results Reference

background

PubMed Identifier

10528819

Citation

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.

Results Reference

background

PubMed Identifier

10698370

Citation

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.

Results Reference

background

PubMed Identifier

12198396

Citation

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.

Results Reference

background

PubMed Identifier

15194205

Citation

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.

Results Reference

background

PubMed Identifier

7978088

Citation

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.

Results Reference

background

PubMed Identifier

16725384

Citation

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.

Results Reference

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PubMed Identifier

10580517

Citation

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.

Results Reference

background

PubMed Identifier

17970166

Citation

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.

Results Reference

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

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