NCT05442255

Brief Summary

The purpose of this study is to carry out a systematic toxicological analysis of all the patients, examined at the UMJ of the Hôtel-Dieu following a complaint for suspected chemical submission. By comparing the toxicological data with the clinical examination data (e.g. treatment intake), the investigators could determine the number of confirmed chemical submissions and the substances involved.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

June 28, 2022

Last Update Submit

September 5, 2025

Conditions

Keywords

Toxicological analysischemical submissionpsychoactive substancesdate rape drug

Outcome Measures

Primary Outcomes (2)

  • Presence of one or more psychoactive substances

    Identify the presence of one or more psychoactive substances in the tests performed (blood).

    Day of inclusion

  • Presence of one or more psychoactive substances

    Identify the presence of one or more psychoactive substances in the tests performed (urines).

    Day of inclusion

Secondary Outcomes (3)

  • Questionnaire

    Day of inclusion

  • Quantification of ethanol

    Day of inclusion

  • Quantification of ethylglucuronide

    Day of inclusion

Study Arms (1)

Chemical Submission

Patients with a suspected chemical submission

Other: Toxicological analysis

Interventions

Automated enzymatic assays Automated Immunoassay Urine Screening High Resolution Toxicological Screening

Chemical Submission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Alleged victims of criminal offences following their filing of a complaint for medical examination on judicial requisition, seen in the Medico-Judicial Unit (UMJ) of the Hôtel-Dieu Hospital in Paris, France.

You may qualify if:

  • Be of legal age (≥ 18) on the day of the exam,
  • Have filed a complaint for a suspected chemical chemical,
  • Be in possession of a judicial requisition requesting the to take biological samples (blood and urine)
  • Claim to be the victim of a suspected chemical chemical submission that took place less than 5 days before the consultation,
  • Be affiliated or entitled to a social security system,
  • Having been informed of the research and not having opposed to his participation.

You may not qualify if:

  • Patient under court protection
  • Minor patient (\< 18 ans),
  • Patient under guardianship,
  • Patient who does not speak French,
  • Patient with psychotic / cognitive symptoms that may impair their judgment,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôtel-Dieu Hospital

Paris, IDF, 75004, France

Location

Related Publications (1)

  • Liautard M, Magny R, Houze P, Deguette C, Alcaraz E, Douaouria S, Gorgiard C, Labat L, Dufayet L. Pro-active drug-facilitated crimes (DFC): a study in the Department of Forensic Medicine of Paris, France. Int J Legal Med. 2024 Mar;138(2):415-430. doi: 10.1007/s00414-023-03090-2. Epub 2023 Sep 28.

    PMID: 37768350BACKGROUND

Study Officials

  • DUFAYET Laurène, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 1, 2022

Study Start

March 1, 2021

Primary Completion

April 15, 2022

Study Completion

July 27, 2022

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations