NCT00673101

Brief Summary

The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,871

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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

January 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

13.5 years

First QC Date

May 6, 2008

Last Update Submit

July 2, 2019

Conditions

Liver Fibrosis

Keywords

liver fibrosis, cirrhosisFibroScantransient elastographyelastometrymethotrexatenon invasive blood markersFibroTesttreatment

Eligibility Criteria

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

Patients treated by Methotrexate

You may qualify if:

  • Male or female subjects, ≥18 years of age.
  • Patient treated with Methotrexate.
  • Written informed consent

You may not qualify if:

  • Patients refusing to participate to the study and to provide written informed consent
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du Haut Leveque

Pessac, 33600, France

Location

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thierry Schaeverbeke, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Edouard Chabrun, MD

    Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, France

    PRINCIPAL INVESTIGATOR

  • Thomas Hubiche, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Marie-Sylvie Doutre, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Maïté Longy-Boursier, MD, PhD

    CHU de Bodeaux

    PRINCIPAL INVESTIGATOR

  • Jean-Luc Pellegrin, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Juliette Foucher, MD

    Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, France

    PRINCIPAL INVESTIGATOR

  • Franck Zerbib, MD PhD

    Gastroenterology and Hepatology Unit, Saint-André Hospital, 33075 Bordeaux, Cedex, France

    PRINCIPAL INVESTIGATOR

  • David Laharie, MD PhD

    University Hospital, Bordeaux

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

January 1, 2006

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

FR(1)