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

NCT04557631 | Withdrawn

• 2 other identifiers: 2019_022019-A02683-54
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

• Frequency of patients with a Peth concentration greater than 200 µg/L

  at the end of study (at 6 months)

Secondary Outcomes (3)

• the concentration of Peth in blood in ambiant temperature

  between T0 and 96h and the end of study (at 6 months)

• the concentration of Peth in blood at 4°C

  between T0 and 96h and the end of study (at 6 months)

• the concentration of Peth in blood in DBS

  between T0 and 4 weeks and the end of study (at 6 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Olivier COTTENCIN, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: September 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 22, 2026

Record last verified: 2026-05