Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol (PETHOXICO)

April 22, 2021 updated by: University Hospital, Lille

For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to:

  • to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature.
  • Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the study will be proposed to all major ethanol-consuming patients with an alcohol use disorder, seen in consultation, in anticipation of hospital withdrawal in addiction service.

Description

Inclusion Criteria:

  • Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria
  • Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions.

Exclusion Criteria:

  • Patient opposing the use of their personal data in the study
  • Patient subject to protective measures (guardianship or curatorship)
  • Person deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of patients with a Peth concentration greater than 200 µg/L
Time Frame: at the end of study (at 6 months)
at the end of study (at 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the concentration of Peth in blood in ambiant temperature
Time Frame: between T0 and 96h and the end of study (at 6 months)
descrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and stored at room temperature,
between T0 and 96h and the end of study (at 6 months)
the concentration of Peth in blood at 4°C
Time Frame: between T0 and 96h and the end of study (at 6 months)
ecrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and at 4°C.
between T0 and 96h and the end of study (at 6 months)
the concentration of Peth in blood in DBS
Time Frame: between T0 and 4 weeks and the end of study (at 6 months)
decrease expressed as a percentage of the initial concentration, in the Dried Blood Spot (DBS)
between T0 and 4 weeks and the end of study (at 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Olivier Cottencin, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_02
  • 2019-A02683-54 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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