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NCT Number: NCT04348838

Prospective Cohort of Patients With Hepatocellular Carcinoma in France

Hepatocellular carcinoma (HCC) occurs in 90% of cirrhosis primary liver cancers. In France, 8,500 new cases of HCC occur each year, and about 8,000 deaths per year are related to this cancer. The 5-year survival rate is 10%, one of the lowest survival rates of all cancer types. HCC raises a number of major challenges: HCC is discovered at a curable stage in only 25% of cases, reflecting the marked delay in the diagnosis of early stages. The state of knowledge about HCC is well behind that of other cancers (no biomarker, complex carcinogenesis, influence of the aetiology, poorly valorised data, etc.). Rapid technological progress requires large-scale studies to evaluate new diagnostic and therapeutic modalities.

The CHIEF project constitutes a common basis knowledge for research project using prospectively collected data in patients with HCC, regardless of the cause and stage of the cancer.

This project is a Multicentre longitudinal observational study of patients with HCC with prospective data collection on inclusion and patient follow-up. Constitution of a biological resources collection. 5,000 patients will be included over 2 years with a follow-up of patients of 5 years.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New cases of HCC
  • suspected case of HCC regardless of the cause, stage, treatment
  • Known HCC: drug treatment for recurrence or progression

Exclusion criteria

  • Associated serious condition threatening life in the short term (with the exception of liver disease itself)
  • So-called vulnerable populations: minors, persons under guardianship or temporary guardianship, or person deprived of their liberty by an administrative or judicial decision

Treatment and study plan

Primary outcomes

  1. Variation of progression free survival (PFS) in intent to treat after liver transplantation

    Time frame: from day 1 of inclusion, up to 5 years

    Variation of progression free survival (PFS) in intent to treat after liver transplantation

  2. Variation of time until failure of the strategy after hepatic resection and percutaneous destruction

    Time frame: from day 1 of inclusion, up to 5 years

    Variation of time until failure of the strategy after hepatic resection and percutaneous destruction

  3. Variation of overall survival time (OS) after chemoembolization

    Time frame: from day 1 of inclusion, up to 5 years

    Variation of overall survival time (OS) after chemoembolization

  4. Variation of overall survival time (OS) after radioembolization

    Time frame: from day 1 of inclusion, up to 5 years

    Variation of overall survival time (OS) after radioembolization

  5. Variation of overall survival time (OS) after pharmaceutical treatment

    Time frame: from day 1 of inclusion, up to 5 years

    Variation of overall survival time (OS) after pharmaceutical treatment

Secondary outcomes

  1. Variation of adverse event rate of HCC treatments in clinical practice

    Time frame: from day 1 of inclusion, up to 5 years

    Variation of adverse event rate of HCC treatments in clinical practice

  2. Variation of serious adverse event rate of HCC treatments in clinical practice

    Time frame: from day 1 of inclusion, up to 5 years

    Variation of serious adverse event rate of HCC treatments in clinical practice

Study contacts

Contact information is provided by the study sponsor or research team.

Gérard DUCOURNAU, Ing

CONTACT

[email protected]

(33)322088376

Olivier Ganry, Pr

CONTACT

[email protected]

(33)322668193

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH)
  • Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT)
  • Biobanque de Picardie
  • Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG)
  • Federation Francophone de Cancerologie Digestive
  • French Association for the Study of the Liver
  • Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR)
  • Societe Francaise de Radiotherapie Oncologique
  • Société Française de Pathologie (SFP)
  • Société Française de Radiologie (SFR)
  • Société Nationale Française de Gastroentérologie
  • UNICANCER

Registry information

Acronym: CHIEF

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2020
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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