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This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients.
The duration of the study is 36 months and it provides a cohort of 200 patients.
At screening, patient will have taken blood samples and performed hepatic vein pressure gradient.
After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines.
In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.
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| Measure | Description | Time Frame |
|---|---|---|
| Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis. | Patients will be subject to blood sample periodically and following exams will be made:
According to current guidelines, patients will be submitted to:
| December 2018 |
| Measure | Description | Time Frame |
|---|---|---|
| Finding of serum metabolomic features of cirrhotic patients. | Analysis will be conducted on sera collected during the screening and every three months. These samples will be examined using liquid chromatography and mass spectrometry in order to obtain the identification of main components and their mass than, the informations will be analyzed by MarkerLynxTM software | December 2018 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with cirrhosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ERICA VILLA, MD | Contact | +39 0594225308 | erica.villa@unimore.it |
| Name | Affiliation | Role |
|---|---|---|
| ERICA VILLA, MD | University of Modena and Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Policlinico Di Modena | Recruiting | Modena | MO | 41124 | Italy |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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