Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Diseases

Liver Cirrhosis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Chronic Graft Versus Host Disease

Hematinics

All Drugs and Chemicals

Liver Extracts

Chronic liver disease patients who are under going standard of care surveillance for the development of HCC as defined by AASLD guidelines.

Chronic liver disease patients who are under going standard of care surveillance for the development of HCC as defined by AASLD guidelines plus the addition of biomarker assays (AFP, AFP-L3 and DCP) every 6 months.

Feld Jordan, MD

The objective of this study is to evaluate the clinical effectiveness of biomarkers, alpha-fetoprotein (AFP), Lens culinaris agglutinin-reactive fraction of AFP (AFP-L3), and des-gamma-carboxy prothrombin (DCP), for surveillance program patients whose hepatocellular carcinoma (HCC) development may be potentially missed by ultrasound (US). This study expects to demonstrate that addition of biomarkers will increase the detection rate by at least 10%.

This study is a prospective randomized controlled trial (RCT) comparing surveillance for hepatocellular carcinoma with ultrasound alone versus ultrasound and standard biomarkers. The study will be conducted initially at UHN (TGH and TWH). One arm will undergo surveillance for hepatocellular carcinoma using ultrasound (US) alone and the other will undergo HCC surveillance with US plus biomarkers (BM). The biomarkers to be used will be AFP, AFP-L3 and DCP). Subjects will undergo surveillance at 6 monthly intervals for a minimum of 2 years and up to 4 years. The endpoints will be the comparative effectiveness, defined as sensitivity and specificity of detection of HCC. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, biomarkers alone, and combined use of US and biomarkers. The target population is individuals who have liver cirrhosis and no HCC detectable at enrollment into the study. The factors contributing to the cause of the cirrhosis will be recorded but will not play a role into subject eligibility for the study

A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers

A Randomized Controlled Trial to Determine the Role of Biomarkers in Surveillance for Hepatocellular Carcinoma (HCC)

Biomarker assay levels that exceed threshold will trigger diagnostic imaging for HCC. Ultrasound imaging indicating a suspicious nodule may also trigger diagnostic imaging.

When the total number of HCC cases as diagnosed by CT/MRI have been observed. Approximately 300 cases in total half (150) the cases from each group

Wako Life Sciences

BORIS GUIU, PU-PH

Christophe Cassinotto, MD, PhD

In France, as in most countries, the incidence of primary liver cancer has increased significantly since the 1980s. In the United States, a study estimating cancer incidence and mortality rates in the coming years predicts that primary liver cancer will become the 3rd leading cause of cancer death from 2030 onwards, behind lung and pancreatic cancer, but ahead of colorectal cancer. This increase in incidence could be explained on the one hand by an increase in the incidence of chronic liver diseases, particularly those related to alcohol and metabolic steatopathies in the West, and on the other hand by improved management of the consequences of cirrhotic disease, which in turn increases the time needed for hepatocellular carcinoma (HCC) to form and develop. The management of a patient with hepatocellular carcinoma is complex because of the underlying cirrhotic disease, which hinders the development of many therapies. Thus, the patient's prognosis depends as much on the tumour extension as on the severity of the underlying chronic liver disease, and the choice of appropriate treatment is based on optimizing the balance between maximum antitumor efficacy and limited liver toxicity.

It is in this context that minimally invasive technical acts, whether local or local-regional, have developed significantly in recent years. Percutaneous tumor destruction techniques have become highly diversified with the development of microwave ablatherm, multipolar radiofrequency, or irreversible electroporation. For intra-arterial treatments, hepatic arterial chemoembolization remains the reference treatment for BCLC B stages. Alongside it, Yttrium 90 radio-embolization is booming, although its precise place remains to be defined in the therapeutic arsenal. Surgical techniques have also progressed, with the development of laparoscopic resections and improved liver transplant management. Finally, external radiotherapy is a recourse solution that can make it possible to propose a therapeutic solution in selected patients.

This multidisciplinary management of the HCC is in constant evolution and improvement, which justifies regularly carrying out an inventory of the frequency of these various technical acts at the national level. The objective of our study is to analyze the evolution, over the last 10 years and at a national level, of the various technical procedures available in the HCC therapeutic arsenal based on data from the french national PMSI database.

Design Observational retrospective epidemiological nationwide cohort

Data source Data will be obtained from the French Programme for the Medicalisation of Information Systems (PMSI) database, which contains all discharge abstracts from all hospitals nationwide. The PMSI includes data on all hospital activities, whether acute (Medecine chirurgiae Obstetrique \[MCO\]), chronic (Soins de Suite et de Réadaptation \[SSR\]), or home-care (Hospitalization à Domicile \[HAD\]). Discharge abstracts include information on the patient's demographics, principal and associated diagnosis codes according to the tenth revision of the International Classification of Diseases (ICD-10) \[10\], procedure codes, mode of hospitalization (elective, emergency, or hospital transfer), mode of discharge (home, hospital transfer, death; the latter was used to compute survival), duration of hospital stay, patient's home address, and hospital identification code. In addition, each patient has an anonymous alphanumerical identifier that enables all hospital admissions throughout the country to be traced. The databases will be provided for the calendar years 2009 to 2018 included.

Data extraction

* date: 01/01/2009 to 31/12/2018
* ICD-10 diagnostic code: C22.0 (liver cell carcinoma - HCC or hepatoma) and C22.9 (malignant neoplasm of liver, unspecified)
* Patient: age, gender, co-morbidities, postal code
* Cause of chronic liver disease, presence of cirrhosis and severity
* 1st diagnosis of HCC or recurrence
* Hospital of care, status and postal code
* Number and type of therapeutic procedures performed per year (each procedure will be counted according to whether it is the first treatment of HCC or the treatment of a recurrence):

  * Liver transplantation
  * Destruction of hepatic tumor by radiofrequency, percutaneous
  * Destruction of hepatic tumor by radiofrequency, intraoperatively
  * Hepatectomy and liver resection:
  * Preoperative portal embolization
  * Liver arterial chemo-embolization:
  * Yttrium 90 Radio Embolization
* Survival from diagnosis and 1st treatment

The expected results of this study are of major importance. On the one hand, this study will provide an overview of the current situation regarding the management of HCC at a national level, by analysing the evolutionary trends of the various therapeutic solutions. The analysis of the geographical variability of care that may exist between different health structures at different levels of expertise, but also at regional or departmental level, is of major importance in order to detect and explain possible differences in terms of prognosis. These data may be of great interest to health authorities or to potential future investigators who will be committed to conducting new prospective projects based on solid and up-to-date data.

Changing Trends in HCC Procedures

Epidemiology of Technical Procedures for the Treatment of Hepatocellular Carcinoma: Country-wide Trends From 2009 to 2019

Quantify at the national level the progression from 2009 to 2019 in the number of procedures performed as part of the treatment of HCC, divided into percutaneous or intraoperative tumour destruction, chemo-embolisation, radio-embolisation, liver surgery and liver transplantation.

look for possible regional disparities according to prognosis and access to innovative care

University Hospital, Montpellier

The complex management of hepatocellular carcinoma has prompted many learned societies to issue their management recommendations or decision-making algorithms to best assist in the therapeutic decision-making of patients with HCC. Over time, the use of the BCLC algorithm (for Barcelona Clinic Liver Cancer) has become essential, at least in the West, thanks to a relatively simple and applicable classification system, and the clinical validation of numerous studies. The BCLC algorithm thus relies on the general condition of the patient, the CHILD-PUGH score reflecting hepatic function, and the tumor extension to propose one or more therapeutic solutions according to the level of scientific evidence, associating with each one. subgroups the expected survival.

While this BCLC classification has the merit of having the protocol for the management of HCC, thus avoiding many drifts related to possible local preferences, it also has many defects. For example, this classification is only rarely updated, which limits the integration of innovative therapies. Then, its design and updates were supported by the recommendations of a limited group of experts that is not necessarily representative of all the key players present daily in the management of CHC. Finally, some studies have begun to point out that this classification was interesting from a theoretical point of view, but that in practice the diversity of complex situations meant that its care recommendations were not applicable in a significant number of cases.

The objective of our study is to analyze the applicability of the BCLC classification in real-life situations. To overcome possible "center effects", the investigators analyzed in an exhaustive way the therapeutic decisions taken during the multi-disciplinary consultation meetings of 2018 and 2019 at the level of a large French region, by relying on the regional network of OncoOccitanie Oncology Record. In a second step, the investigators will analyze the causes of the discrepancies to finally propose an improvement of this BCLC classification.

Discrepancies in Management of Hepatocellualr Carcinoma Between Practice and Recommendations

Management of Hepatocellular Carcinoma : Discrepancies Between BCLC Classification and Clinical Practice in a Large Regional Multicentric Cohort

Rate of therapeutic proposals correctly predicted by the BCLC international classification

Study title	NCT ID	Conditions	Eligibility	Organization
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...	18 Years -	Wako Life Sciences
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...	18 Years -	Wako Life Sciences
A Protocol of the Canadian Prospective Study for Hepatocellular Carcinoma Surveillance Using Biomarkers	NCT02272504	Cirrhosis Chronic Liver D...	18 Years -	Wako Life Sciences
Changing Trends in HCC Procedures	NCT04163627	Hepatocellular ...	18 Years -	University Hospital, Montpellier
Discrepancies in Management of Hepatocellualr Carcinoma Between Practice and Recommendations	NCT04189809	Hepatocellular ...	18 Years -	University Hospital, Montpellier

Spots Global Cancer Trial Database for chronic liver diseases