deltatrials
Completed OBSERVATIONAL NCT00708617

FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease (FIBROMAF)

Non Invasive Diagnostic Methods for Fibrosis in Alcoholic Liver Disease : FIBROSCAN Validation and Comparison of Fibrotest - FIBROSCAN Association With FIBROSCAN Alone

Sponsor: Assistance Publique - Hôpitaux de Paris

Updated 6 times since 2017 Last updated: Jan 22, 2014 Started: Sep 30, 2008 Primary completion: Jul 31, 2013 Completion: Jul 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00708617, this observational or N/A phase trial focuses on Alcoholic Liver Disease and remains completed. Sponsored by Assistance Publique - Hôpitaux de Paris, it has been updated 6 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Alcoholic liver disease (ALD) is highly prevalent and liver fibrosis and cirrhosis are asymptomatic for a long time. Liver biopsy in patients with ALD is designed to determine the prognostic of the liver lesions and to manage cirrhosis. Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) are already used in current practice. The aim of this study is to validate the diagnostic value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this diagnostic strategy. 200 consecutive excessive drinkers with aminotransferase anomalies or suspicion of cirrhosis will be included in the study over a period of 2 years. All patient will have intercostal liver biopsy, assessment of the non-invasive biological scores of liver fibrosis and transient elastography. Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve of the scores will be compared using...

Alcoholic liver disease (ALD) is highly prevalent and liver fibrosis and cirrhosis are asymptomatic for a long time. Liver biopsy in patients with ALD is designed to determine the prognostic of the liver lesions and to manage cirrhosis. Apart from Fibrotest, non-invasive markers have been validated only for chronic hepatitis C. However as for chronic C hepatitis, non invasive tests (Fibrotest and transient elastometry) are already used in current practice. The aim of this study is to validate the diagnostic value of FIBROSCAN by comparison with liver histology. FIBROSCAN will be also compared to Fibrotest and FIBROSCAN-Fibrotest association to each test alone in order to optimize this diagnostic strategy.

200 consecutive excessive drinkers with aminotransferase anomalies or suspicion of cirrhosis will be included in the study over a period of 2 years. All patient will have intercostal liver biopsy, assessment of the non-invasive biological scores of liver fibrosis and transient elastography.

Studied variables will be significant fibrosis (≥ 2 in the METAVIR score) and presence of cirrhosis (score : F4). Diagnostic values of the scores will be expressed by sensitivity, specificity, positive and negative predictive values, and ROC curves. Areas under ROC curve of the scores will be compared using Z test. Multivariate analyses will be used to identify the scores with an independent diagnostic value and therefore that could be associated.

This study will allow to select the non-invasive marker(s) with the best diagnostic values in order to identify early fibrosis in patients with ALD.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotCompleted~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed

  2. Jul 2024 — Sep 2024 [monthly]

    Completed

  3. Jan 2021 — Jul 2024 [monthly]

    Completed

  4. Jun 2018 — Jan 2021 [monthly]

    Completed

  5. Apr 2018 — Jun 2018 [monthly]

    Completed

    Phase: NANone

Show 1 earlier version
  1. Jan 2017 — Apr 2018 [monthly]

    Completed NA

    First recorded

Sep 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Assistance Publique - Hôpitaux de Paris
  • Echosens
Data source: Assistance Publique - Hôpitaux de Paris

For direct contact, visit the study record on ClinicalTrials.gov .