Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease
This study has been completed.
Sponsor:
Erasme University Hospital
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00610597
First received: January 28, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | January 28, 2008 | ||||
| Last Updated Date | January 28, 2008 | ||||
| Start Date ICMJE | January 2005 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease | ||||
| Official Title ICMJE | Study of T Cell Phenotype Activation Pathway in Human Alcoholic Liver Disease | ||||
| Brief Summary | Alcoholic liver disease is characterized by circulating T cell activation and liver T cell infiltration but their phenotype is poorly studied. The aim of the study is to test the hypothesis that the (CD4+ T cell secreting Interleukin-17) Th17 pathway is involved in alcoholic liver disease. |
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| Detailed Description | Consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis C virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver T cell infiltrates. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: plasma and peripheral blood mononuclear cell culture medium. |
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| Sampling Method | Probability Sample | ||||
| Study Population | patients of Erasme University Hospital |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Lemmers A, Moreno C, Gustot T, Maréchal R, Degré D, Demetter P, de Nadai P, Geerts A, Quertinmont E, Vercruysse V, Le Moine O, Devière J. The interleukin-17 pathway is involved in human alcoholic liver disease. Hepatology. 2009 Feb;49(2):646-57. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 49 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | January 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00610597 | ||||
| Other Study ID Numbers ICMJE | AL-ALD, AL-ALD | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Olivier Le Moine, MD, PhD, Erasme University Hospital | ||||
| Study Sponsor ICMJE | Erasme University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Erasme University Hospital | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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