Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Hepatitis A

Hepatitis C

Hepatitis

Hepatitis, Chronic

Virus Diseases

Lymphoma, B-Cell

Hepatitis C, Chronic

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Communicable Diseases

Enterovirus Infections

Picornaviridae Infections

RNA Virus Infections

Blood-Borne Infections

Flaviviridae Infections

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

B-cell Lymphoma

Olivier HERMINE, PU-PH

Fabrice CARRAT, PU-PH

An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.

Main objectives are:

* Description of the clinical and histological characteristics, treatment and evolution of these NHL.
* Study their physiopathology by immunological, virologic and molecular studies.

The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments.

The enrolment period is 6 years and the total study lasts 8 years.

* "Prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years.
* "Retropective patients" are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.

The enrollment is estimated at 140 patients.

Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)

Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus

the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics

to evaluate the correlation between hematological and virological response

ANRS, Emerging Infectious Diseases

Heart and Blood Diseases

Hypertension

Hypertension, Portal

Fibrosis

Hepatitis B

Hepatitis B, Chronic

Liver Neoplasms

Hepadnaviridae Infections

DNA Virus Infections

Gastrointestinal Neoplasms

Digestive System Neoplasms

Herpes Simiae (B Virus)

Hematinics

All Drugs and Chemicals

Liver Extracts

Norihisa Yada, M.D.

Kazuomi Ueshima, M.D.

Masatoshi Kudo, Professor

This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.

The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients.

Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed.

Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months.

The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.

Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography

Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography

Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais

Cancer-free survival is defined as the time from registration to death due to cencer or any cause

Overall survival is defined as the time from registration to death due to any cause

It is estimated by gastrointestinal scope for every year

Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.

Kindai University

Japan Liver Oncology Group Organization:

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Anti-Infective Agents

Antineoplastic Agents

Interferons

Ribavirin

Peginterferon alfa-2a

Antimetabolites

Antiviral Agents

100 naïve CHC patients concomitant with hepatocellular carcinoma without clinical evidence of HCC recurrence more than 3 months after curative treatments.

100 naïve CHC patients without malignancy

They received peginterferon alpha-2a (180 μg/week) and weight-based ribavirin 1000-1200 mg/day, with a 24-week follow-up period.

peginterferon alpha-2a and ribavirin

Wan-Long Chuang, MD

Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in chronic hepatitis C patients concomitant with hepatocellular carcinoma deserve to be elucidated.

The purposes of this study are:

1. To evaluate the efficacy and safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.
2. To investigate the role of baseline and on-treatment factors on the response to pegylated interferon-alpha 2a plus ribavirin combination therapy in chronic hepatitis C patients concomitant with hepatocellular carcinoma.

A prospective, hospital-based study enrolling 100 chronic hepatitis C patients concomitant with hepatocellular carcinoma and other sex- and age-matched 100 chronic hepatitis C patients without malignancy will be conducted. The 100 chronic hepatitis C patients concomitant with hepatocellular carcinoma will receive pegylated interferon-alpha 2a plus ribavirin combination therapy at remission phase after oncological treatments and/or interventions. The other 100 chronic hepatitis C patients without malignancy receiving the same antiviral therapy will serve as controls. The primary outcome measurement is sustained virological response and safety, whilst the secondary measurement is rapid virological and early virological response.

Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

The Response and Outcomes of Pegylated Interferon Plus Ribavirin Combination Therapy for Chronic Hepatitis C Patients Concomitant With Hepatocellular Carcinoma

Kaohsiung Medical University Chung-Ho Memorial Hospital

Wan-Long Chuang, MD.

Liver Cirrhosis

Central Nervous System Depressants

Lipid Regulating Agents

Ethanol

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Angiotensin-Converting Enzyme Inhibitors

Group conformed by patients experiencing improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.

Group conformed by patients not showing the predefined improvement in the noninvasive markers of fibrosis, Fibrotest/Fibrosure and transient elastography, while enrolled in the study.

Regression of fibrosis will be defined by assessing yearly evolution of noninvasive markers in patients who received antiviral therapy before start of the study, and by comparing baseline markers before start of antiviral therapy to those on subsequent yearly visits in patients prospective recruited (\>50% of cases).

Regression of fibrosis

Such as: family history of liver cancer; body mass index; alcohol, smoking and recreational drug use status; dietary habits, including use of caffeinated drinks; comorbidities such as type 2 diabetes mellitus; use of medications for other chronic diseases such as statins and angiotensin-converting enzyme inhibitors.

Specific risk factors related to hepatocellular carcinoma

Andres Duarte-Rojo, MD, MSc

Jonathan A Dranoff, MD

This study aims to demonstrate that patients with chronic hepatitis C (CHC) and B (CHB) experiencing regression of liver cirrhosis after effective antiviral therapy have decreased risk for hepatocellular carcinoma (HCC). Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.

Cirrhosis is the final pathway of chronic liver disease, and up to 30% of patients develop hepatocellular carcinoma (HCC) within 5 years of diagnosis of cirrhosis. Worldwide, chronic hepatitis C (CHC) and B (CHB) account for the majority of cases of cirrhosis. Successful antiviral treatment results in regression of fibrosis in the majority of patients. Surveillance programs for early detection of HCC mandate the use of imaging (ultrasound/CT-scan) every 6 months. It has been shown in CHC and CHB that the risk of HCC is greatly reduced after viral disease is eradicated/inactive. However, the impact that regression of fibrosis and other factors could have in abating the incidence of HCC has not been systematically investigated. Currently, all patients with eradicated/inactive viral disease continue to be enrolled in HCC surveillance programs, generating anxiety in patients and very high costs to our healthcare system. Fibrotest (FT) and transient elastography (TE) are noninvasive tools proven to be useful for serial assessment of liver fibrosis.

OBJECTIVES: The proposed hypothesis is that patients with regression of liver fibrosis have decreased risk for HCC. Primary aim is to determine the incidence of HCC in patients with cirrhosis secondary to CHC and CHB, during the 3-7 years after treatment is provided, and to identify the magnitude of the decreased risk for HCC in patients experiencing regression of fibrosis. As a secondary aim, environmental risk factors for HCC development will be sought, in order to determine a subset of patients in whom it will be safe to stop surveillance.

METHODS: Patients 18-70 year-old with cirrhosis will be identified from hepatology clinics in 4 academic centers in North America. FT/TE will be obtained before the start of antivirals and yearly thereafter (prospective arm). A retrolective arm of all patients treated no earlier than Jan/2009 will also be included. In this group, baseline FT/TE will be performed off treatment (CHC) or after initial phase of therapy (CHB), and yearly thereafter. During baseline and yearly visits other factors possibly affecting HCC development will be investigated (family history, comorbidities, BMI, diet, etc.). Patients will be classified as having or having not undergone regression of fibrosis after a 3-year follow up, depending on FT and TE evolution. During follow up, all patients will undergo 6-month imaging as part of their routine HCC surveillance. Based on power calculations, enrollment should stop after 924 patients have been recruited. Kaplan-Meier and Cox regression models will be used to analyze data.

PATIENT OUTCOMES: ROLFH study uses state-of-the-art noninvasive markers of liver fibrosis to test whether reversed fibrosis decreases the risk of HCC. We believe this study will lead to a better understanding of HCC risk factors, improved patient counseling and decision making, optimized screening and allocation of health resources, and decreased healthcare costs.

The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study

According to Fibrotest/Fibrosure and transient elastography

According to standard imaging surveillance protocol, and confirmatory CT/MRI/biopsy

Positive family history of liver cancer, BMI, active/previous smoking, active/previous alcohol consumption, caffeine consumption in diet, diabetes mellitus, use of drugs for chronic medical conditions

Composite of regression of fibrosis plus other specific conditions decreasing incidence of hepatocellular carcinoma to \<1.5% / year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)	NCT01545544	Chronic Hepatit...		18 Years -	ANRS, Emerging Infectious Diseases
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography	NCT01360892	Chronic Hepatit... Chronic Hepatit...		20 Years -	Kindai University
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)	NCT01545544	Chronic Hepatit...		18 Years -	ANRS, Emerging Infectious Diseases
Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Hepatocellular Carcinoma	NCT00834860	Chronic Hepatit... Hepatocellular ...	peginterferon a...	18 Years -	Kaohsiung Medical University Chung-Ho Memorial Hospital
The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study	NCT01831037	Chronic Hepatit... Chronic Hepatit...	Regression of f... Specific risk f...	18 Years - 70 Years	University of Arkansas
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography	NCT01360892	Chronic Hepatit... Chronic Hepatit...		20 Years -	Kindai University

Spots Global Cancer Trial Database for chronic hepatitis c