NCT03084185

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 13, 2017

Status Verified

March 1, 2017

Enrollment Period

6 years

First QC Date

March 8, 2017

Last Update Submit

September 12, 2017

Conditions

Cirrhosis

Keywords

decompensationdeficitmetabolomicsportal hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

    December 2018

Secondary Outcomes (1)

  • Finding of serum metabolomic features of cirrhotic patients.

    December 2018

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with cirrhosis

You may qualify if:

  • Diagnosis of liver cirrhosis
  • Aged between 18 and 75 years
  • Obtaining written informed consent

You may not qualify if:

  • Diagnosis of hepatocellular carcinoma
  • Presence of portal vein thrombosis
  • HIV
  • Liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico Di Modena

Modena, MO, 41124, Italy

RECRUITING

MeSH Terms

Conditions

FibrosisHypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • ERICA VILLA, MD

    University of Modena and Reggio Emilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ERICA VILLA, MD

CONTACT

+39 0594225308erica.villa@unimore.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 20, 2017

Study Start

December 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)