Liquid Biopsy for NASH and Liver Fibrosis

NCT04677101 | Completed

• 1 other identifier: 20201612
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

NASH - Nonalcoholic Steatohepatitis; Liver Fibroses

Outcome Measures

Primary Outcomes (1)

• The primary aim of our study is to validate blood non-invasivebiomarker sensitivity and accuracy in predicting NASH and fibrosis stage.

  2 months

Study Arms (2)

Subjects with NASH documented by liver biopsy

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.

Diagnostic Test: Liver Biopsy

Healhy Donor

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

Diagnostic Test: Liver Biopsy

Interventions

Liver Biopsy DIAGNOSTIC_TEST

Fine-needle liver biopsy

Healhy Donor; Subjects with NASH documented by liver biopsy

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (2)

University of Rome Sapienza

Roma, Italy

Location

Catholic University School of Medicine

Rome, 00168, Italy

Location

Related Publications (1)

• Angelini G, Panunzi S, Castagneto-Gissey L, Pellicano F, De Gaetano A, Pompili M, Riccardi L, Garcovich M, Raffaelli M, Ciccoritti L, Verrastro O, Russo MF, Vecchio FM, Casella G, Casella-Mariolo J, Papa L, Marini PL, Rubino F, le Roux CW, Bornstein S, Mingrone G. Accurate liquid biopsy for the diagnosis of non-alcoholic steatohepatitis and liver fibrosis. Gut. 2023 Feb;72(2):392-403. doi: 10.1136/gutjnl-2022-327498. Epub 2022 Jul 12.

  PMID: 35820779 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: December 16, 2020
• Primary Completion: March 16, 2021
• Study Completion: April 16, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)