Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis
NCT ID: NCT03083002
Last Updated: 2017-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
250 participants
OBSERVATIONAL
2013-05-31
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study
NCT00629421
To Study the Effects of Host Genetic Factors on Liver Cirrhosis and Hepatocellular Carcinoma (HCC)
NCT00709085
Study of Hepatocellular Carcinoma in Cirrhotic Patients
NCT01904942
PROtocol of Metabolic and Cryptogenic livEr Disease regisTry for intEgration of Omic Studies
NCT04371042
Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease and Hepatocellular Cancer
NCT01034865
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study have four research lines:
Task # 1: transcriptomic characterization of liver tissue. During hepatic vein pressure gradient , liver tissue will be extracted with transjugular catheter equipped with a biopsy device. Tissue will be used to extract microRNA to define molecular signature.
Task # 2: Proteomic characterization of liver tissue. Protein expression changes will be analyze with MALDI-TOF
Task # 3: Metabolomic features on serum of patient with cirrhosis. Metabolomics is defined as the quantitative measurement of the dynamic multiparametric response of living systems to pathophysiological stimulus or genetic modification. Principal objective of this activity will be identify metabolites deregulated with metabolomic approach and clarify any new pathways involved in the evolution of cirrhosis to hepatocellular carcinoma.
The metabolomic analysis will be performed on sera collected in patients with cirrhosis at baseline.
Task # 4: Transcriptomic characteristics of newly diagnosed HCC. New diagnosis of hepatocellular carcinoma will undergo an eco-assisted liver biopsy. A tissue sample will be dedicated to the extraction of 'RNA. Patients will then undergo elective treatment according to international guidelines. The course of the disease and the results of therapeutic interventions will be recorded and correlated with the molecular data. Molecular signature will be obtain.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Liver cirrhosis
* Aged between 18 and 75 years
Exclusion Criteria
* HIV
* Pregnancy
* Portal vein thrombosis
* Liver Transplant
* Patients' refusal to participate in clinical research
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Modena and Reggio Emilia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
ERICA VILLA
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ERICA VILLA
Role: PRINCIPAL_INVESTIGATOR
Università di Modena e Reggio Emilia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Azienda Ospedaliera Universitaria Policlinico Di Modena
Modena, MO, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UNIRER 2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.