Liquid Biopsy for NASH and Liver Fibrosis

NASH - Nonalcoholic Steatohepatitis Clinical Trial

— LIBRA  

Official title:

Liquid Biopsy as a Non-invasive Tool for the Diagnosis of NASH and Liver Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677101
• Other study ID #: 20201612
• Status: Completed
• Start date: December 16, 2020
• Est. completion date: April 16, 2021

Study information

• Verified date: May 2021
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Nonalcoholic fatty liver disease (NAFLD) has evolved to represent the most common cause of chronic liver disease globally. Today, NAFLD is a leading indication for liver transplantation and a major etiology for hepatocellular carcinoma (HCC) in the United States. NAFLD is characterized by the excess accumulation of lipids within the liver and ranges from isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by the presence of hepatic necroinflammation, hepatocyte ballooning and fibrosis progression.

Currently, liver biopsy remains the gold standard for the diagnosis of various chronic liver diseases, and for determining the severity of liver injury, inflammation, and fibrosis stage. However, this procedure is invasive, prone to complications such as bleeding and is associated with sampling variability and limited representation of the whole liver. Other limitations include, the difficulty to monitor liver injury progression over time and underestimation of disease severity.

Despite intensive research, currently available non-invasive blood tests are not sufficiently sensitive or specific and are therefore of limited use. Blood biomarkers might provide significant advances in the diagnosis and monitoring of disease progression and regression in clinical settings.

Recently, liquid biopsy has emerged as a potential, less invasive, alternative to liver biopsy. In fact, it addresses several unmet clinical needs, including sensitivity, specificity, the determination of prognoses, and the prediction of therapeutic responses.

Description:

This is a multicentric prospective observational study to validate blood non-invasive biomarkers for NASH and fibrosis stage.

150 subjects will be enrolled; 100 subjects with biopsy-proven NASH and 50 subjects with normal liver will be used as controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 16, 2021
• Est. primary completion date: March 16, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI =30 and =55 kg/m2.

Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.

Exclusion Criteria:

Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (>20 g/day for women or >30 g/day for men); Wilson's disease; Lipodystrophy; Parenteral nutrition; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Fibroses
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Diagnostic Test:
• Liver Biopsy
Fine-needle liver biopsy

Locations

Country	Name	City	State
Italy	University of Rome Sapienza	Roma
Italy	Catholic University School of Medicine	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim of our study is to validate blood non-invasivebiomarker sensitivity and accuracy in predicting NASH and fibrosis stage.		2 months