Hepatitis, Viral, HumanFIBROSTICNCT00318682
Evaluation and Medico-Economic Study of FIBROSCAN in Patients With Viral Hepatitis
An observational study of Hepatitis, Viral, Human, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Viral, Human
- What is being tested?
- FIBROSCAN
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 2 sitesFrance
- Study dates
- May 2006to Aug 2008
- 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: patient with hepatitis B or C
Who may be able to join
- Chronic hepatitis B or C
- With liver biopsy indication
- Patient information
Who cannot join
- Drug hepatitis
- Metabolic hepatology
- Steatosis or non-alcoholic steatohepatitis
- Autoimmune hepatopathy
- Non-contraindication to liver biopsy
- Non-contraindication to FIBROSCAN examination
- Ascites
- Obesity
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis
A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. This transversal study aims to compare the evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550 consecutive patients taken in charge for a liver biopsy. The results of the study will compare the respective performances of these techniques in the prediction of the METAVIR score, and help in the recommendation of the care of patients with viral hepatitis B and C; these methods will undergo a medico-economic study.
Read the detailed description
The gold standard for the evaluation of fibrosis is considered as the METAVIR score by the clinicians. The results of this score are currently used for clinical decisions and description of the evolution of the disease. FIBROSCAN would be interesting in avoiding liver biopsies, if it was able to predict accurately the METAVIR score obtained if a liver biopsy was performed. The data available on diagnostic performances of FIBROSCAN are incomplete, the number of patients studied and the methods selection (blindness of the results of other techniques) are not precise in some of them. The main objective of this study is therefore to evaluate the performance of FIBROSCAN in the prediction of METAVIR score > 2 (vs F0 or F1). An ancillary study will try to evaluate the diagnostic performance of FIBROSCAN in the global prediction of METAVIR score. A statistical method will be tested using the reference method as an ordinal polytropic variable. Half of the sample (1250 patients) will be used to determine the best THERSHOLD of FIBROSCAN in each of the clinical subgroups of patients, in order to obtain a high sensibility. The second half will be used as the validation sample, and the threshold will be used to estimate the sensibility, specificity and other diagnostic parameters of the FIBROSCAN. The secondary objectives are:
- to evaluate the performance of FIBROSCAN in the prediction of METAVIR score in adjacent classes of fibrosis (F0-F1, F1-F2, F2-F3, F3-F4), and
- to study the association between elastometry and fibrosis surface obtained by morphometry (considered as the best evaluation of global liver fibrosis).
This technique will be applied to a restricted number of biopsies (consecutive biopsies > 2cm).
- Conditions
- Hepatitis, Viral, Human
- Being tested
- FIBROSCAN
- Keywords
- biopsy, FIBROSCAN
- Medical subject headings
- Hepatitis, Viral, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIBROSCANDevice
diagnostic examination of the hepato fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: enough patients have been enrolled for the statistic analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, Viral, HumanStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Francoise Degos, PhD, Principal investigator, Hopital Beaujon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318682
- Sponsor's protocol ID
- IC0504
- Acronym
- FIBROSTIC
- Status last verified
- Sep 2006
- First submitted
- 25 Apr 2006
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Medico Economic Study of FIBROSCAN in Patients With Viral Hepatitis
- ClinicalTrials.gov ID
- NCT00318682
- Acronym / sponsor ID
- FIBROSTIC / IC0504
- Conditions
- Hepatitis, Viral, Human
- Keywords
- biopsy, FIBROSCAN
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: enough patients have been enrolled for the statistic analysis
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Apr 2006 (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.
A new approach to the evaluation of liver fibrosis has been proposed using PULSOMETRY. The objective is to evaluate the diagnostic performances of the FIBROSCAN technique, together with non-invasive techniques, and to determine how it is able to predict the histological fibrosis score, defined by the METAVIR score. This transversal study aims to compare the evaluation of hepatic fibrosis obtained by FIBROSCAN and histology (METAVIR score) in 2550 consecutive patients taken in charge for a liver biopsy. The results of the study will compare the respective performances of these techniques in the prediction of the METAVIR score, and help in the recommendation of the care of patients with viral hepatitis B and C; these methods will undergo a medico-economic study.
Detailed description
The gold standard for the evaluation of fibrosis is considered as the METAVIR score by the clinicians. The results of this score are currently used for clinical decisions and description of the evolution of the disease. FIBROSCAN would be interesting in avoiding liver biopsies, if it was able to predict accurately the METAVIR score obtained if a liver biopsy was performed. The data available on diagnostic performances of FIBROSCAN are incomplete, the number of patients studied and the methods selection (blindness of the results of other techniques) are not precise in some of them. The main objective of this study is therefore to evaluate the performance of FIBROSCAN in the prediction of METAVIR score > 2 (vs F0 or F1). An ancillary study will try to evaluate the diagnostic performance of FIBROSCAN in the global prediction of METAVIR score. A statistical method will be tested using the reference method as an ordinal polytropic variable. Half of the sample (1250 patients) will be used to determine the best THERSHOLD of FIBROSCAN in each of the clinical subgroups of patients, in order to obtain a high sensibility. The second half will be used as the validation sample, and the threshold will be used to estimate the sensibility, specificity and other diagnostic parameters of the FIBROSCAN. The secondary objectives are:
- to evaluate the performance of FIBROSCAN in the prediction of METAVIR score in adjacent classes of fibrosis (F0-F1, F1-F2, F2-F3, F3-F4), and
- to study the association between elastometry and fibrosis surface obtained by morphometry (considered as the best evaluation of global liver fibrosis).
This technique will be applied to a restricted number of biopsies (consecutive biopsies > 2cm).
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
- patient with hepatitis B or C
Key inclusion criteria (3 listed)
- Chronic hepatitis B or C
- With liver biopsy indication
- Patient information
Key exclusion criteria (8 listed)
- Drug hepatitis
- Metabolic hepatology
- Steatosis or non-alcoholic steatohepatitis
- Autoimmune hepatopathy
- Non-contraindication to liver biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIBROSCANdiagnostic examination of the hepato fibrosis | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: enough patients have been enrolled for the statistic analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
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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.
Francoise Degos, PhD principal investigator
Hopital Beaujon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, Viral, Human, run by Assistance Publique - Hôpitaux de Paris at 2 sites 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 8 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: stopped early, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: enough patients have been enrolled for the statistic analysis). Results are not available in the source record.
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 12 Feb 2009.