Biomarkers in the Diagnosis and Prognosis of NAFLD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Trieste
About this trial
Fibrosis is considered the leading cause of liver diseases and related mortality. Specifically, hepatic fibrosis is regarded as the consequence of reparative mechanisms initiated by hepatocytes in response to chronic damage. In Western countries, the main known etiologies include hepatitis (B and C), alcoholism, and non-alcoholic steatohepatitis (NASH). In particular, obesity is a determining factor in the onset and development of NASH. Alarming statistical data indicate that over 30% of the world's population is obese, and this eating disorder is increasingly affecting young people. NASH is a chronic disease that can present different degrees of fibrosis and, as the final stage, lead to the development of liver cirrhosis. Currently, the only accurate diagnostic and assessment system for this condition is liver biopsy, as there are no accurate non-invasive clinical tests available. The aim of this project is to identify (in silico) potential biomarkers involved in the development and progression of hepatic fibrosis and validate their presence and quantity in serum or plasma samples from obese patients (at-risk population). This would avoid the need for a liver biopsy and allow "at-risk" patients to undergo a simple ambulatory blood draw. Additionally, performing elastometry of the liver would allow for comparison of radiological results with laboratory findings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients affected by active liver viral infection
Patient alcohol or drug addicted
Incompetent patients
Trial population
Patients with obesity eligible for bariatric surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Plasma Test
Diagnostic testIGF-2 (insulin-like growth factor 2)
Plasma test
Diagnostic testSPARC (secreted protein acidic and rich in cysteine)
Plasma test
Diagnostic testEPICAN (heparan sulfate proteoglycan)
Plasma test
Diagnostic testEGFR (epidermal growth factor receptor)
Liver biopsy
Diagnostic testFibrosis and steatosis grade according to Brunt-Kleiner classification
Visceral adipose tissue biopsy
Diagnostic testPresence of inflammation
Liver elastography
Diagnostic testGrade of fibrosis according to Hamaguchi score
Blood test
Diagnostic testDetermination of surrogate based diagnostic tests/scores for liver fibrosis
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
soluble biomarkers of liver fibrosis
To identify (through in silico analysis) and validate new biomarkers that are useful for the diagnosis and prognosis of NAFLD, which can be used in non-invasive clinical tests.
Time frame
Time of enrollment. At baseline, before collecting liver biopsy during bariatric surgerySecondary outcomes
1
Follow-up
Evaluating plasma biomarkers at 6 -12 months after surgery
Time frame
6 -12 months after surgery2
Correlation analysis
Correlation between surrogate based score and plasma biomarkers
Time frame
At baseline and 6-12 months after surgery3
Correlation analysis
Correlation between plasma biomarkers and Hamaguchi score at elastography
Time frame
At baseline and 12 months after surgery4
Biobank
Creation of tissue (liver, vat, blood) bank
Time frame
At baseline and at the time of bariatric surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov