Retrospective Cohort of Patients Diagnosed With HCC on Non-Cirrhotic LiverCHAMADNCT07145385
Prevalence of Alpha-1 Antitrypsin Deficiency in Non-Cirrhotic Liver Cancer
An observational study of Retrospective Cohort of Patients Diagnosed With HCC on Non-Cirrhotic Liver, run by University Hospital, Bordeaux at 1 site in France.
Trial 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 cirrhotic and non-cirrhotic livers, highlighting AATD as a potential oncogenic factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retrospective Cohort of Patients Diagnosed With HCC on Non-Cirrhotic Liver
- What is being tested?
- multiplex digital PCR
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Diagnosed with HCC on non-cirrhotic liver
Who may be able to join
- 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
Show all 9Show fewer
- Metabolic-associated steatohepatitis (MASH)
- Viral hepatitis infections
- Hemochromatosis
Who cannot join
- 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
Show all 9Show fewer
- Metabolic-associated steatohepatitis (MASH)
- Viral hepatitis infections
- Hemochromatosi
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Bordeaux
Bordeaux
Marion Decraecker, MD, +335 57 65 64 38, marie.decraecker@chu-bordeaux.fr
About this study
Official title: Prevalence of Alpha-1 Antitrypsin Deficiency in a Cohort of Hepatocellular Carcinoma on Non-Cirrhotic Liver Without Identified Etiologies
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
Read the 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 without known risk factors for HCC
- Being tested
- multiplex digital PCR
- Keywords
- Prevalence, Alpha-1 Antitrypsin Deficiency, HCC on Non-Cirrhotic Liver, Retrospective Cohort
- Medical subject headings
- alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiplex digital PCROther
multiplex digital PCR
| Study group | Role | What they receive |
|---|---|---|
| Patients Diagnosed with HCC on Non-Cirrhotic Liver | Patients Diagnosed with HCC on Non-Cirrhotic Liver Receives: Other: multiplex digital PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Alpha-1 Antitrypsin Deficiency
Prevalence of Alpha-1 Antitrypsin Deficiency in a Retrospective Cohort of Patients Diagnosed with HCC on Non-Cirrhotic Liver up to 1 year
Measured: 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
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startJan 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retrospective Cohort of Patients Diagnosed With HCC on Non-Cirrhotic LiverStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145385
- Sponsor's protocol ID
- CHUBX 2024/43
- Acronym
- CHAMAD
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beaufrere A, Leon C, Decreaker M, Possenti L, Evain M, Coilly A, Schneider CV, Feurer Z, Odou MF, Balduyck M, Payance A, Schneider KM, Bioulac P, Blanc JF, Le Bail B, Guettier C, Amintas S, Bouchecareilh M. Alpha-1 Antitrypsin Deficiency Alleles in Non-Cirrhotic Hepatocellular Carcinoma: Insights from a Multicenter French Cohort. J Clin Exp Hepatol. 2026 Jul-Aug;16(4):103545. doi: 10.1016/j.jceh.2026.103545. Epub 2026 Apr 3.
PubMed 42064227
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Alpha-1 Antitrypsin Deficiency in a Cohort of Hepatocellular Carcinoma on Non-Cirrhotic Liver Without Identified Etiologies
- ClinicalTrials.gov ID
- NCT07145385
- Acronym / sponsor ID
- CHAMAD / CHUBX 2024/43
- Keywords
- Prevalence, Alpha-1 Antitrypsin Deficiency, HCC on Non-Cirrhotic Liver, Retrospective Cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 without known risk factors for HCC
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Diagnosed with HCC on Non-Cirrhotic Liver | – | Other: multiplex digital PCRPatients Diagnosed with HCC on Non-Cirrhotic Liver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Diagnosed with HCC on non-cirrhotic liver
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiplex digital PCRmultiplex digital PCR | Other | Patients Diagnosed with HCC on Non-Cirrhotic Liver |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Derived from this study: PubMed 42064227Beaufrere A, Leon C, Decreaker M, Possenti L, Evain M, Coilly A, Schneider CV, Feurer Z, Odou MF, Balduyck M, Payance A, Schneider KM, Bioulac P, Blanc JF, Le Bail B, Guettier C, Amintas S, Bouchecareilh M. Alpha-1 Antitrypsin Deficiency Alleles in Non-Cirrhotic Hepatocellular Carcinoma: Insights from a Multicenter French Cohort. J Clin Exp Hepatol. 2026 Jul-Aug;16(4):103545. doi: 10.1016/j.jceh.2026.103545. Epub 2026 Apr 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retrospective Cohort of Patients Diagnosed With HCC on Non-Cirrhotic Liver, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Decraecker, MD (+335 57 65 64 38, marie.decraecker@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Alpha-1 Antitrypsin Deficiency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07145385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.