Evaluation of the Threshold for the Interpretation of the... | NCT04557631

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

NCT04557631

Sponsor

University Hospital, Lille

Status

Withdrawn

Last Update Posted

May 22, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Alcohol Abuse

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A02683-54	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sponsor décision COVID

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Nov 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Sep 15, 2020

First Submission Date that Met QC Criteria

Sep 15, 2020

First Posted Date

Sep 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
the concentration of Peth in blood in ambiant temperature	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier COTTENCIN, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided