Liver FibrosisMethoscanNCT00673101
Prospective Evaluation of FibroScan in Patients Treated With Methotrexate
An observational study of Liver Fibrosis, run by Association HGE CHU Bordeaux Sud at 1 site in France.
Trial summary
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis
- How many people
- 1,871 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated by Methotrexate
Who may be able to join
- Male or female subjects, ≥18 years of age.
- Patient treated with Methotrexate.
- Written informed consent
Who cannot join
- Patients refusing to participate to the study and to provide written informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Liver Fibrosis Using FibroScan and Non-invasive Biochemical Markers in Patients Treated With Methotrexate
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.
Read the detailed description
Methotrexate (MTX) is an effective treatment for induction of remission and maintenance in patients with Crohn's disease, rheumatoid arthritis, or psoriasis which may induce liver fibrosis with high cumulative doses. Transient elastography (FibroScan) is a new non-invasive rapid, reproducible and bed-side method, allowing assessment of liver fibrosis by measurement of liver stiffness. A preliminary study (Laharie et al, Alimentary Pharmaceutical Therapeutics 2006) had shown that significant liver fibrosis was rare in Crohn's disease patients treated with a high dose of methotrexate. FibroScan was a reliable non-invasive method to detect liver fibrosis which could be recommended in these patients. Therefore, liver biopsy could be performed only with patients with high FibroScan values and/or with chronic liver enzymes abnormalities. However, further longitudinal and prospective studies are mandatory to confirm these preliminary data, in patients with crohn's disease but also with rheumatoid arthritis and psoriasis.
- Conditions
- Liver Fibrosis
- Keywords
- liver fibrosis, cirrhosis, FibroScan, transient elastography, elastometry, methotrexate, non invasive blood markers, FibroTest, treatment
- Medical subject headings
- Liver Cirrhosis, Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association HGE CHU Bordeaux Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, de Ledinghen, Association HGE CHU Bordeaux Sud
- Investigators
- Thierry Schaeverbeke, MD, PhD, Principal investigator, University Hospital, BordeauxEdouard Chabrun, MD, Principal investigator, Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, FranceThomas Hubiche, MD, Principal investigator, University Hospital, BordeauxMarie-Sylvie Doutre, MD, PhD, Principal investigator, University Hospital, BordeauxMaïté Longy-Boursier, MD, PhD, Principal investigator, CHU de BodeauxJean-Luc Pellegrin, MD, PhD, Principal investigator, University Hospital, BordeauxJuliette Foucher, MD, Principal investigator, Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, FranceFranck Zerbib, MD PhD, Principal investigator, Gastroenterology and Hepatology Unit, Saint-André Hospital, 33075 Bordeaux, Cedex, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673101
- Sponsor's protocol ID
- 05-07
- Acronym
- Methoscan
- Status last verified
- Jul 2019
- First submitted
- 6 May 2008
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Fibrosis Using FibroScan and Non-invasive Biochemical Markers in Patients Treated With Methotrexate
- ClinicalTrials.gov ID
- NCT00673101
- Acronym / sponsor ID
- Methoscan / 05-07
- Conditions
- Liver Fibrosis
- Keywords
- liver fibrosis, cirrhosis, FibroScan, transient elastography, elastometry, methotrexate, non invasive blood markers, FibroTest, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,871 participants (actual)
- Lead sponsor
- Association HGE CHU Bordeaux SudUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate liver fibrosis using FibroScan and biochemical markers in patients treated with methotrexate.
Detailed description
Methotrexate (MTX) is an effective treatment for induction of remission and maintenance in patients with Crohn's disease, rheumatoid arthritis, or psoriasis which may induce liver fibrosis with high cumulative doses. Transient elastography (FibroScan) is a new non-invasive rapid, reproducible and bed-side method, allowing assessment of liver fibrosis by measurement of liver stiffness. A preliminary study (Laharie et al, Alimentary Pharmaceutical Therapeutics 2006) had shown that significant liver fibrosis was rare in Crohn's disease patients treated with a high dose of methotrexate. FibroScan was a reliable non-invasive method to detect liver fibrosis which could be recommended in these patients. Therefore, liver biopsy could be performed only with patients with high FibroScan values and/or with chronic liver enzymes abnormalities. However, further longitudinal and prospective studies are mandatory to confirm these preliminary data, in patients with crohn's disease but also with rheumatoid arthritis and psoriasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by Methotrexate
Key inclusion criteria (3 listed)
- Male or female subjects, ≥18 years of age.
- Patient treated with Methotrexate.
- Written informed consent
Key exclusion criteria (2 listed)
- Patients refusing to participate to the study and to provide written informed consent
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Schaeverbeke, MD, PhD principal investigator
University Hospital, Bordeaux
Edouard Chabrun, MD principal investigator
Gastroenterology and Hepatology Unit, Haut-Lévêque Hospital, 33604 Pessac, France
Thomas Hubiche, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis, run by Association HGE CHU Bordeaux Sud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.