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

NCT ID: NCT04557631

Last Updated: 2021-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olivier COTTENCIN, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olivier COTTENCIN, MD,PhD

Role: CONTACT

0320445962 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A02683-54

Identifier Type: OTHER

Identifier Source: secondary_id

2019_02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gastric Emptying With Trou Normand
NCT06728761 RECRUITING NA
Combined Effects of Alcohol and Caffeine
NCT01289561 COMPLETED PHASE1