Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C

NCT00399815 | Unknown

• 1 other identifier: ELASTO2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic viral hepatitis C is a frequent liver disease. It is associated with variable degree of hepatic fibrosis. To date, liver histology is still regarded as the gold standard to detect, diagnose and quantify liver fibrosis. This requires to perform a liver biopsy. Severe complications are associated to this procedure in 0.01 to 0.1% of cases. Because of this, the repetition of the biopsy to evaluate the progression of the disease or the response to treatment poses ethical questions. Also, liver biopsy only explore a minimal portion of the liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated. To avoid risks linked to invasive technique and sampling errors associated to liver biopsy, efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis. In this study we will perform in patients with chronic hepatitis C, serum tests, fibroscan (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver parenchyma by MRI. This study will allow

• to determine whether non-invasive tests effectively measure liver fibrosis
• to compare each non-invase test with results of liver biopsy
• to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis C.

Conditions

Hepatitis C, Chronic

Keywords

Chronic viral hepatitis C; HCV RNA; Fibroscan; Fibrotest; hepatic elastography by MRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic hepatitis C

You may qualify if:

• alteration of liver function tests (ALT, AST)
• HCV RNA positive

You may not qualify if:

• clotting disorder
• ongoing treatment with anti-coagulant or anti-aggregant
• advanced or decompensated cirrhosis (Child-Pugh class C)
• hepatocellular carcinoma
• other cancer
• history of surgery for brain aneurysm
• pace maker or defibrillator
• ocular metal foreign body

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires StLuc, Université catholique de Louvain (UCL)

Brussels, 1200, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

liver biopsy serum

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yves J Horsmans, M.D., Ph.D.

  Cliniques Universitaires StLuc, Université catholique de Louvain (UCL), Brussels, Belgium

  STUDY DIRECTOR

Central Study Contacts

Yves J Horsmans, M.D., Ph.D.

CONTACT

32 2 764 28 37; horsmans@gaen.ucl.ac.be

Bernard VanBeers, M.D.,

CONTACT

32 2 764 29 45; vanbeers@rdgn.ucl.ac.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2006
• First Posted: November 15, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

BE (1)