Liver FibrosisSNIFF11NCT00453869
Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail
An observational study of Liver Fibrosis, run by University Hospital, Angers at 1 site in France.
Trial summary
The prevalence of chronic hepatopathies is high in jail. However, the medical care of these hepatopathies is few developed. This study is an observational, an epidemiologic (screening and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care of these hepatopathies in jail. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- liver fibrosis evaluation
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Mar 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All subjects in jail who have a medical evaluation.
Who may be able to join
- Person over 18,
- All new inmates, for less than one month, in Angers jail,
- To have a written informed consent.
Who cannot join
- No consent obtained from person,
- Detention inferior to one month,
- Person under 18.
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of chronic hepatopathies is high in jail. However, the medical care of these hepatopathies is few developed. This study is an observational, an epidemiologic (screening and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and virological status) with FibroScan® as gold standard; to evaluate the feasibility of these different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors, alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.
Read the detailed description
Primary outcome: Screening of clinically significant fibrosis with FibroMeter blood score. Screening for hepatitis B and hepatitis C viruses.
Secondary outcome: Clinically significant fibrosis confirmed with FibroScan®.
The means for this study are a clinical questionnaire, a virological screening, a blood score for liver fibrosis: FibroMeter according to cause of the fibrosis and FibroScan® is referent and independent examination.
The expected results from this study are the knowledge of the prevalence of hepatopathies with hepatic fibrosis will be able to justify, possibly, a screening politic of them. This study will permit to evaluate the feasibility of noninvasive screening of the liver fibrosis in the goal to suppress the liver biopsy in a population having numerous drawbacks.
- Conditions
- Liver Fibrosis
- Being tested
- liver fibrosis evaluation
- Keywords
- Liver fibrosis, Hepatitis B virus and C virus, FibroMeter, FibroScan®
- Medical subject headings
- Liver Cirrhosis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver fibrosis evaluationOther
Evaluation of liver fibrosis with blood test
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fibrosis evaluation
Evaluation of liver fibrosis with blood tests
Measured: D0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Few prevalence of liver fibrosis in subjects
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.
- More trials run by University Hospital, AngersThe 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paul CALES, MD, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453869
- Sponsor's protocol ID
- PHRC 2006-05
- Other IDs
- DGS 2006-0142 ; CPP 2006/27bis
- Acronym
- SNIFF11
- Status last verified
- Dec 2014
- First submitted
- 28 Mar 2007
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail
- ClinicalTrials.gov ID
- NCT00453869
- Acronym / sponsor ID
- SNIFF11 / PHRC 2006-05
- Conditions
- Liver Fibrosis
- Keywords
- Liver fibrosis, Hepatitis B virus and C virus, FibroMeter, FibroScan®
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Few prevalence of liver fibrosis in subjects
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Mar 2007 (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 prevalence of chronic hepatopathies is high in jail. However, the medical care of these hepatopathies is few developed. This study is an observational, an epidemiologic (screening and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and virological status) with FibroScan® as gold standard; to evaluate the feasibility of these different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors, alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.
Detailed description
Primary outcome: Screening of clinically significant fibrosis with FibroMeter blood score. Screening for hepatitis B and hepatitis C viruses.
Secondary outcome: Clinically significant fibrosis confirmed with FibroScan®.
The means for this study are a clinical questionnaire, a virological screening, a blood score for liver fibrosis: FibroMeter according to cause of the fibrosis and FibroScan® is referent and independent examination.
The expected results from this study are the knowledge of the prevalence of hepatopathies with hepatic fibrosis will be able to justify, possibly, a screening politic of them. This study will permit to evaluate the feasibility of noninvasive screening of the liver fibrosis in the goal to suppress the liver biopsy in a population having numerous drawbacks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects in jail who have a medical evaluation.
Key inclusion criteria (3 listed)
- Person over 18,
- All new inmates, for less than one month, in Angers jail,
- To have a written informed consent.
Key exclusion criteria (3 listed)
- No consent obtained from person,
- Detention inferior to one month,
- Person under 18.
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 |
|---|---|---|
| liver fibrosis evaluationEvaluation of liver fibrosis with blood test | Other | – |
Primary outcome
Liver fibrosis evaluation
Time frame: D0
Evaluation of liver fibrosis with blood tests
Results and safety
The study was stopped early (reason given: Few prevalence of liver fibrosis in subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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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.
Paul CALES, MD, PhD principal investigator
UH Angers
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 University Hospital, Angers 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 3 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 Dec 2014. 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 was stopped early (reason given: Few prevalence of liver fibrosis in subjects). 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.
What does the primary outcome measure?
Liver fibrosis evaluation (time frame: D0). It is what the study was designed to measure, not a finding.
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 Dec 2014.