NCT05213442

Brief Summary

Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease). The evaluation of these liver disorders in psychiatric inpatients remains very little explored in France, contributing to the poor overall medical status of psychiatric patients. The LIVERSPIN study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

January 26, 2022

Last Update Submit

February 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • HCV diagnosis

    HCV diagnosis defined by positive HCV antibodies in blood

    At inclusion

Secondary Outcomes (4)

  • HBV diagnosis

    At inclusion

  • HIV diagnosis

    At inclusion

  • Suspicion of NAFLD

    At inclusion

  • Suspicion of alcoholic liver disease

    At inclusion

Study Arms (1)

All inpatients in Vinatier psychiatric Hospital

OTHER

All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.

Diagnostic Test: To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.

Interventions

Patients will receive the usual clinical and paraclinical examinations as part of their hospitalization diagnostic workup. For the biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination. Data will be collected from the patient, or if necessary from the health care team, using the medical record (interview and/or self-questionnaires).

All inpatients in Vinatier psychiatric Hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years old
  • Social insurance
  • Current hospitalization in any psychiatric unit of the participating center
  • Adult or legal representative who has given written and informed consent to participate in the study. By default, the oral consent of the adult will be obtained (as well as the written consent of the legal representative)
  • Information given to the curator(for people under curatorship)

You may not qualify if:

  • \- Clinical state of the patient which do not allow the collection of study data (according to the investigator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678 cedex, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Benjamin ROLLAND, MD, PhD

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Monocentric, non randomized, non comparative cross-sectional study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

January 28, 2022

Study Start

April 6, 2022

Primary Completion

December 15, 2023

Study Completion

December 15, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations