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NCT Number: NCT07145385

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

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 cirrhotic and non-cirrhotic livers, highlighting AATD as a potential oncogenic factor. Therefore, our aim is to evaluate the association between AATD and HCC in patients with a non-cirrhotic liver and no known predisposition

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Key information

Conditions

Retrospective Cohort of Patients Diagnosed With HCC on Non-Cirrhotic Liver Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Emphysema Genetic Diseases, Inborn Liver Diseases Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Subcutaneous Emphysema alpha 1-Antitrypsin Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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 without known risk factors for HCC

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

multiplex digital PCR

Other

multiplex digital PCR

Primary outcomes

  1. Prevalence of Alpha-1 Antitrypsin Deficiency

    Time frame: 1 year

    Prevalence of Alpha-1 Antitrypsin Deficiency in a Retrospective Cohort of Patients Diagnosed with HCC on Non-Cirrhotic Liver up to 1 year

Secondary outcomes

  1. Correlation of clinico-biological parameters-including survival (years), sex, BMI, fibrosis stage, mode of diagnosis, number of tumors, tumor size (mm), metastasis, recurrence, and Edmondson score-according to AAT genotype

    Time frame: 1 year

    Correlation of clinico-biological parameters-including survival (years), sex, BMI, fibrosis stage, mode of diagnosis, number of tumors, tumor size (mm), metastasis, recurrence, and Edmondson score-according to AAT genotype. up to 1 year

Study contacts

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

Marie Decraecker, MD

CONTACT

[email protected]

+335 57 65 64 38

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Prevalence of Alpha-1 Antitrypsin Deficiency in a Cohort of Hepatocellular Carcinoma on Non-Cirrhotic Liver Without Identified Etiologies

Acronym: CHAMAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2025
Registry last updated
Jan 5, 2026

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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