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
1 other identifier
observational
4,000
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 16, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
June 16, 2026
June 1, 2026
1.4 years
June 11, 2026
June 11, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Patient Clinical Characteristics
Type of HCC at diagnosis
8 Years
Patient demographics
Disease duration in years
8 Years
Tumor characteristics
Severity of liver disease on presentation as assessed by the Child-Turcotte-Pugh (CTP) score and classes
8 Years
Secondary Outcomes (4)
To describe the risk factors (etiology) of HCC
8 Years
To describe the treatment patterns in patients with HCC
8 Years
To describe the overall survival rate (OS)
8 Years
To Describe Progression Free Survival
8 Years
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 16, 2026
Study Start
June 30, 2026
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
November 30, 2027
Last Updated
June 16, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.