CHARM Hepatocellular Carcinoma MEA Study
A Multicountry, Multicenter, Secondary Data Collection, Retrospective Observational Study to Describe the Characteristics and Management of Hepatocellular Carcinoma (HCC) Among Adults in the Middle East Region
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
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Dammam, Arabia Saudita
- Aún no reclutando
- Research Site
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Jeddah, Arabia Saudita
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Mecca, Arabia Saudita
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Riyadh, Arabia Saudita
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Al Mansurah, Egipto
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- Research Site
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Dakahlia, Egipto
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- Research Site
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Damietta, Egipto
- Aún no reclutando
- Research Site
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Menouf, Egipto
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- Research Site
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Abu Dhabi, Emiratos Árabes Unidos
- Aún no reclutando
- Research Site
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Al Ain City, Emiratos Árabes Unidos
- Reclutamiento
- Research Site
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Doha, Katar
- Aún no reclutando
- Research Site
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Kuwait City, Kuwait
- Aún no reclutando
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Rabat, Marruecos
- Aún no reclutando
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Ankara, Turquía (Türkiye)
- Aún no reclutando
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Erzurum, Turquía (Türkiye)
- Aún no reclutando
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Istanbul, Turquía (Türkiye)
- Aún no reclutando
- Research Site
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Izmir, Turquía (Türkiye)
- Aún no reclutando
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
- Patients with medical records covering at least a 6-month follow-up period, defined as the time from the index date (the date of the first diagnosis) to the earliest of the following: the patient's death, the last medical record entry, or the data extraction date. Additionally, patients who died within this 6-month period will also be included.
Exclusion Criteria:
- 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
- Pregnant patient
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient Clinical Characteristics
Periodo de tiempo: 8 Years
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Type of HCC at diagnosis
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8 Years
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Patient demographics
Periodo de tiempo: 8 Years
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Disease duration in years
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8 Years
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Tumor characteristics
Periodo de tiempo: 8 Years
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Severity of liver disease on presentation as assessed by the Child-Turcotte-Pugh (CTP) score and classes
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8 Years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To describe the risk factors (etiology) of HCC
Periodo de tiempo: 8 Years
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Proportion of patients with each risk factor:
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8 Years
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To describe the treatment patterns in patients with HCC
Periodo de tiempo: 8 Years
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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:
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8 Years
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To describe the overall survival rate (OS)
Periodo de tiempo: 8 Years
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Patient survival stratified by participating countries: o OS |
8 Years
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To Describe Progression Free Survival
Periodo de tiempo: 8 Years
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The date of each progression from stage to another stage.
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8 Years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D419CR00057
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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