About this trial
Hepatocellular carcinoma (HCC) is the sixth most commonly diagnosed cancer and the third reason for cancer-related death worldwide. Cirrhosis is a common risk factor of HCC, as it is found in approximately 70-90% of patients with HCC. Hepatitis C (HCV) and alcohol consumption represent the main causes of cirrhosis and HCC in Western countries; however, hepatitis B virus (HBV) is the leading cause of HCC and cirrhosis in East Asia and Africa. Moreover, HBV and HCV are considered the most common causes of HCC in about 80%-90% of patients. In addition, steatotic liver disease (SLD) is considered one of the main causes of HCC and cirrhosis. Unfortunately, the burden of HCC is great in Middle Eastern and North African (MENA) countries because of the high prevalence of HCV and HBV and the increasing incidence of SLD and metabolic-associated steatohepatitis (MASH).
Several studies illustrated that there are great disparities in the survival rate of patients with HCC according to patient characteristics such as gender, age, and socioeconomic status. In addition, the etiology of HCC may impact the survival and the response to treatment. Moreover, the incidence of HCC could be decreased by the prevention and/or appropriate management of HCC risk factors, especially HBV, HCV infections, and SLD. Therefore, understanding the etiology, patient characteristics, pathogenesis, and optimal management of HCC in the region is considered of prime importance to improve the patient journey of HCC in the MENA region.
The Middle East encompasses countries with varying levels of healthcare development and resources. There is a significant disparity in access to diagnostic tools, therapeutic options, and liver transplantation services. While some countries possess advanced healthcare systems with state-of-the-art facilities, others face challenges such as limited healthcare infrastructure, shortage of specialized healthcare professionals, and inadequate screening programs. These disparities significantly affect the early detection, management, and outcomes of HCC patients.
This study aims to assess the etiology, clinical and tumor characteristics, and treatments received for HCC, as well as clinical outcomes (OS, PFS) in different countries in the MENA region.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a radiological or histopathological confirmed diagnosis with HCC in any stage of the tumor between 1st January 2015 and 31st December 2023 (defined as index date).
Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written informed consent according to the local regulations
Age 18 years or older, and a lawful adult in the country at the index date
Patients with medical records, including etiology, laboratories, radiological, and treatment details will be collected from the participating sites.
Disqualifiers
Patients with other cancer diagnosis on or before index date.
Patients with records missing information on etiology, laboratory results, radiological findings, or treatment details (≥30% of key variables).
Previously opted out of sharing medical records
Patients participating in clinical trials
Trial population
Data from patients' medical charts will be gathered from 3 to 5 tertiary referral centers per country across 10 countries in the MENA region, including Egypt, KSA, the United Emirates, Lebanon, Kuwait, Qatar, Iraq, Morocco, Jordan, and Turkey. The study population comprises patients diagnosed with HCC between January 1, 2015, and December 31, 2023, across these participating centers.
Trial design
Other
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Patient Clinical Characteristics
Type of HCC at diagnosis
Patient demographics
Disease duration in years
Tumor characteristics
Severity of liver disease on presentation as assessed by the Child-Turcotte-Pugh (CTP) score and classes
Secondary outcomes
To describe the risk factors (etiology) of HCC
Proportion of patients with each risk factor: * Viral hepatitis (B, C, and D). * ALD * SLD
To describe the treatment patterns in patients with HCC
The percentage of patients receiving each of the following treatment regimens alone or in combination, along with the duration, and treatment discontinuation frequency and reasons in different countries: * Tumor resection * Liver transplantation * Local ablation (ethanol, radiofrequency, microwave) * TACE (conventional, drug-eluting beads (DEB) * TARE (Yttrium-9- Microspheres, Lipiodol labelled with iodine131 or rhenium188) * Tyrosine kinase inhibitors (Sorafenib, Lenvatinib, Regorafenib, Cabozantinib) * Immune checkpoint inhibitors (Nivolumab, Pembrolizumab, Atezolizumab, Tislelizumab, Durvalumab, Tremelimumab)
To describe the overall survival rate (OS)
Patient survival stratified by participating countries: o OS
To Describe Progression Free Survival
The date of each progression from stage to another stage.
Sponsors and contacts
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