Alcoholic Liver DiseaseNCT01128010
Role of CCL2 in Alcoholic Liver Diseases
An observational study of Alcoholic Liver Disease, run by Erasme University Hospital.
Trial summary
Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic liver disease. Serum levels and liver expression of CCL2 are increased in patients with alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver disease is nevertheless unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Liver Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients undergoing transjugular liver biopsy for alcoholic liver disease will be include in the study to measure plasma levels and hepatic expression of CCL2. We determine also the rs1024611 polymorphism of these patients. All these parameters are correlated to severity of the disease. The frequency of the presence of this polymorphism was also compared to a population of healthy subjects.
Who may be able to join
- Excess alcohol intake
- Abnormality of liver biopsy compatible with alcoholic aetiology
- Caucasian ethnicity
Who cannot join
- Presence of any other chronic liver disease
- co-infection with HIV Controls Inclusion criteria
- Caucasian ethnicity
- presence of a disease
About this study
Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic liver disease. Serum levels and liver expression of CCL2 are increased in patients with alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver disease is nevertheless unknown. The aim of the study is to analyze plasma level and liver expression of CCL2 and their relation with liver disease severity and inflammatory infiltrate in our cohort of alcoholic patients. We studied also the association between -2518 CCL2 polymorphism and the severity of alcoholic liver disease.
- Conditions
- Alcoholic Liver Disease
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| alcoholic liver disease | alcoholic liver disease patients undergoing a transjugular liver biopsy in our institution | |
| controls | Healthy controls patients recruited from the Occupational Medicine Department during a routine physical examination |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128010
- Sponsor's protocol ID
- DD-CCL2
- Status last verified
- Dec 2002
- First submitted
- 20 May 2010
- Last updated
- 21 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of CCL2 in Alcoholic Liver Diseases
- ClinicalTrials.gov ID
- NCT01128010
- Acronym / sponsor ID
- DD-CCL2
- Conditions
- Alcoholic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- First posted
- 21 May 2010 (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.
Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic liver disease. Serum levels and liver expression of CCL2 are increased in patients with alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver disease is nevertheless unknown. The aim of the study is to analyze plasma level and liver expression of CCL2 and their relation with liver disease severity and inflammatory infiltrate in our cohort of alcoholic patients. We studied also the association between -2518 CCL2 polymorphism and the severity of alcoholic liver disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcoholic liver disease | – | –alcoholic liver disease patients undergoing a transjugular liver biopsy in our institution |
| controls | – | –Healthy controls patients recruited from the Occupational Medicine Department during a routine physical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing transjugular liver biopsy for alcoholic liver disease will be include in the study to measure plasma levels and hepatic expression of CCL2. We determine also the rs1024611 polymorphism of these patients. All these parameters are correlated to severity of the disease. The frequency of the presence of this polymorphism was also compared to a population of healthy subjects.
Key inclusion criteria (3 listed)
- Excess alcohol intake
- Abnormality of liver biopsy compatible with alcoholic aetiology
- Caucasian ethnicity
Key exclusion criteria (4 listed)
- Presence of any other chronic liver disease
- co-infection with HIV Controls Inclusion criteria
- Caucasian ethnicity
- presence of a disease
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 21 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Disease, run by Erasme University Hospital.
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 4 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 21 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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 21 May 2010.