CirrhosisNCT03084185
Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .
An observational study of Cirrhosis, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Dec 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with cirrhosis
Who may be able to join
- Diagnosis of liver cirrhosis
- Aged between 18 and 75 years
- Obtaining written informed consent
- Absence of exclusion criteria
Who cannot join
- Diagnosis of hepatocellular carcinoma
- Presence of portal vein thrombosis
- HIV
- Liver transplantation
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Di Modena
Modena, MO, 41124
ERICA VILLA, MD, 0594225308, erica.villa@unimore.it
erica.villa@unimore.it
About this study
Official title: Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.
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.
Read the detailed description
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.
- Conditions
- Cirrhosis
- Keywords
- decompensation, deficit, metabolomics, portal hypertension
- Medical subject headings
- Fibrosis, Hypertension, Portal
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Chemistry and hematology to define liver function
- Intestinal Fatty Acid Binding Protein
- 16S, ribosomal deoxyribonucleic acid
- Cluster of differentiation 14
- Interleukin 6
- Asymmetrical dimethylarginine
- Tissue factor
According to current guidelines, patients will be submitted to:
- Hepatic vein pressure gradient AND combined right heart catheterization
- Liver elastography
Measured: December 2018
Secondary outcomes (1)
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
Measured: December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startDec 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERICA VILLA, University of Modena and Reggio Emilia
- Investigators
- ERICA VILLA, MD, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084185
- Sponsor's protocol ID
- HVPG_HCV
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.
- ClinicalTrials.gov ID
- NCT03084185
- Acronym / sponsor ID
- HVPG_HCV
- Conditions
- Cirrhosis
- Keywords
- decompensation, deficit, metabolomics, portal hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Mar 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cirrhosis
Key inclusion criteria (4 listed)
- Diagnosis of liver cirrhosis
- Aged between 18 and 75 years
- Obtaining written informed consent
- Absence of exclusion criteria
Key exclusion criteria (4 listed)
- Diagnosis of hepatocellular carcinoma
- Presence of portal vein thrombosis
- HIV
- Liver transplantation
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
Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis.
Time frame: December 2018
Patients will be subject to blood sample periodically and following exams will be made: * Chemistry and hematology to define liver function * Intestinal Fatty Acid Binding Protein * 16S, ribosomal deoxyribonucleic acid * Cluster of differentiation 14 * Interleukin 6 * Asymmetrical dimethylarginine * Tissue factor According to current guidelines, patients will be submitted to: * Hepatic vein pressure gradient AND combined right heart catheterization * Liver elastography
1 secondary outcome
Finding of serum metabolomic features of cirrhotic patients.
Time frame: December 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Individual participant dataSharing planned: No
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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.
ERICA VILLA, MD principal investigator
University of Modena and Reggio Emilia
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 Cirrhosis, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Sep 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ERICA VILLA, MD (+39 0594225308, erica.villa@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis. (time frame: December 2018). 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 13 Sep 2017.