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CHARM Hepatocellular Carcinoma MEA Study

2. september 2026 oppdatert av: AstraZeneca

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.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

4000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • De forente arabiske emirater
      • Abu Dhabi, De forente arabiske emirater
        • Har ikke rekruttert ennå
        • Research Site
      • Al Ain City, De forente arabiske emirater
        • Rekruttering
        • Research Site
  • Egypt
      • Al Mansurah, Egypt
        • Har ikke rekruttert ennå
        • Research Site
      • Dakahlia, Egypt
        • Har ikke rekruttert ennå
        • Research Site
      • Damietta, Egypt
        • Har ikke rekruttert ennå
        • Research Site
      • Menouf, Egypt
        • Har ikke rekruttert ennå
        • Research Site
  • Kuwait
      • Kuwait City, Kuwait
        • Har ikke rekruttert ennå
        • Research Site
  • Marokko
      • Rabat, Marokko
        • Har ikke rekruttert ennå
        • Research Site
  • Qatar
      • Doha, Qatar
        • Har ikke rekruttert ennå
        • Research Site
  • Saudi-Arabia
      • Dammam, Saudi-Arabia
        • Har ikke rekruttert ennå
        • Research Site
      • Jeddah, Saudi-Arabia
        • Har ikke rekruttert ennå
        • Research Site
      • Mecca, Saudi-Arabia
        • Har ikke rekruttert ennå
        • Research Site
      • Riyadh, Saudi-Arabia
        • Har ikke rekruttert ennå
        • Research Site
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye)
        • Har ikke rekruttert ennå
        • Research Site
      • Erzurum, Tyrkia (Türkiye)
        • Har ikke rekruttert ennå
        • Research Site
      • Istanbul, Tyrkia (Türkiye)
        • Har ikke rekruttert ennå
        • Research Site
      • Izmir, Tyrkia (Türkiye)
        • Har ikke rekruttert ennå
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Clinical Characteristics
Tidsramme: 8 Years
Type of HCC at diagnosis
8 Years
Patient demographics
Tidsramme: 8 Years
Disease duration in years
8 Years
Tumor characteristics
Tidsramme: 8 Years
Severity of liver disease on presentation as assessed by the Child-Turcotte-Pugh (CTP) score and classes
8 Years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To describe the risk factors (etiology) of HCC
Tidsramme: 8 Years

Proportion of patients with each risk factor:

  • Viral hepatitis (B, C, and D).
  • ALD
  • SLD
8 Years
To describe the treatment patterns in patients with HCC
Tidsramme: 8 Years

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)
8 Years
To describe the overall survival rate (OS)
Tidsramme: 8 Years

Patient survival stratified by participating countries:

o OS
8 Years
To Describe Progression Free Survival
Tidsramme: 8 Years
The date of each progression from stage to another stage.
8 Years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. juli 2026

Primær fullføring (Antatt)

30. november 2027

Studiet fullført (Antatt)

30. november 2027

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D419CR00057

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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