Status:

NOT_YET_RECRUITING

Prevalence of Alpha-1 Antitrypsin Deficiency in Non-Cirrhotic Liver Cancer

Lead Sponsor:

University Hospital, Bordeaux

Conditions:

Retrospective Cohort of Patients Diagnosed With HCC on Non-Cirrhotic Liver

Eligibility:

All Genders

18+ years

Brief Summary

Patients with Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic disease, have a 20- to 50-fold higher risk of developing primary liver cancer (PLC), such as hepatocellular carcinoma (HCC), in both...

Detailed Description

The two most common pathogenic AATD variants, PiS and PiZ, will be identified using the multiplex digital PCR (dPCR) system in a French cohort of 71 patients who developed HCC in a non-cirrhotic liver...

Eligibility Criteria

Inclusion

  • Adult patients (≥18 years of age).
  • Histopathologically confirmed diagnosis of hepatocellular carcinoma (HCC).
  • Normal liver or chronic liver disease with minimal to moderate fibrosis in non-tumoral tissue.
  • Signed informed consent obtained prior to participation.
  • No other known etiology or risk factors for liver disease, including:
  • Alcohol-related liver disease
  • Metabolic-associated steatohepatitis (MASH)
  • Viral hepatitis infections
  • Hemochromatosis

Exclusion

  • Minor patients (\<18 years of age).
  • HCC diagnosis not established according to standard histopathological criteria.
  • Liver with chronic liver disease showing advanced fibrosis in non-tumoral tissue.
  • No signed informed consent prior to participation.
  • Presence of other identified etiologies or known risk factors for liver disease, including:
  • Alcohol-related liver disease
  • Metabolic-associated steatohepatitis (MASH)
  • Viral hepatitis infections
  • Hemochromatosi

Key Trial Info

Start Date :

January 1 2026

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

71 Patients enrolled

Trial Details

Trial ID

NCT07145385

Start Date

January 1 2026

End Date

September 1 2027

Last Update

January 5 2026

Active Locations (1)

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1

CHU Bordeaux

Bordeaux, France