Cirrhosis With Hepatocellular CarcinomaCIRCENCT01798173
Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
A study testing Serum, plasma and DNA samples and Radiological exploration by CT scan or MRI in people with Cirrhosis With Hepatocellular Carcinoma and Cirrhosis Without Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire Dijon at 6 sites in France.
Trial summary
Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well understood in absence of studies taking into account all recognised factors. A large scale clinical, biochemical and molecular studies is potentially relevant to the understanding of nutrition, physical activity, body weight… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cirrhosis With Hepatocellular Carcinoma, Cirrhosis Without Hepatocellular Carcinoma
- What is being tested?
- Serum, plasma and DNA samples and Radiological exploration by CT scan or MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,246 participants
- Where
- 6 sitesFrance
- Study dates
- 20 Jun 2008to 25 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases and controls will be males and females aged 35 or older, and will give an informed consent to participate in the study.
- Hepatocellular carcinoma case:
- All hepatocellular carcinoma cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. Criteria for the diagnosis of hepatocellular carcinoma will be those defined by the European Association for Study of the Liver (EASL) (Bruix J, J Hepatol 2001):
- Focal hepatic lesions ≥ 2cm in diameter:
- alpha-fetoprotein (AFP) < 400 ng/ml: nodules have to be identified by at least two coincident morphologic examinations (abdominal US, angiography, CT or MRI) with arterial hypervascularisation in at least one of the imaging modalities
- AFP > 400 ng/ml: lesion seen in a single imaging modality
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- Focal hepatic lesions < 2 cm in diameter:
- lesions 1 to 2 cm in diameter:use of fine-needle aspiration with biopsy
- lesions < 1 cm: serial abdominal US every 3 months until the lesion exceeds 1 cm in size so that biopsy becomes possible. Such cases will be included after diagnosis confirmation.
- Whatever the size of focal lesions, the diagnosis of cirrhosis will be made according to the same criteria as in the cirrhotic group control.
- Cirrhotic control patients:
- All patients with cirrhosis, whatever its etiology, will be included. The diagnosis of cirrhosis will rely on:
- Histological confirmation by liver biopsy or in the absence of biopsy:
- in patients free of portal thrombosis at Doppler imaging, on the presence of portal hypertension ascertained by biological (tricytopenia), morphologic (abdominal US, CT or MRI), hepatic venous pressure measurement or upper endoscopy (mosaic gastropathy, varices).
- in patients with portal thrombosis, on the presence of portal hypertension associated with: Clinical (hepatomegaly with clinical evidence of hepatocellular failure: spider naevi, palmar erythema, white mails, gynecomastia) or morphological signs of cirrhosis (enlarged liver, nodular surface, sharp lower edge).
- And/or biological signs of hepatocellular failure (TP<70%, low albuminemia) And/or sinusoidal block assessed by liver venous gradient > 18mmHG In the present state of knowledge, a fibrotest value at 4 or a fibroscan value > 12.5 kilopascal.
- Without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral C hepatitis.
- The lack of hepatocellular carcinoma in cirrhotic patients at inclusion will be assessed through good quality imaging examinations (abdominal US, CT scan or MRI) and AFP below 100 ng/ml.
Who cannot join
- age under 35 of year
- other cancer in evolution
- HIV infection
- Major somatic pr psychiatric illness not compatible with the inclusion in the study
- No hepatocellular carcinoma primary liver cancer.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Jean Minjoz
Besançon, 25000
Hôpital du Bocage
Dijon, 21079
Centre Hospitalier de METZ
Metz, 57038
CHU Robert DEBRE
Reims, 51092
Clinique médicale B. Hôpital Civil-Hôpitaux Universitaires
Strasbourg, 67091
Hôpital de BRABOIS
Vandœuvre-lès-Nancy, 54511
About this study
Official title: CIRCE: Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well understood in absence of studies taking into account all recognised factors. A large scale clinical, biochemical and molecular studies is potentially relevant to the understanding of nutrition, physical activity, body weight metabolic syndrome whatever the etiology of underlying cirrhosis. It will open new perspectives :
- in prevention of hepatocellular carcinoma development in cirrhotic patients through dietary counselling and therapeutics of metabolic syndrome,
- in early screening of hepatocellular carcinoma in cirrhotic patients through spectroscopic technology and later proteomic study resulting in an improvement of hepatocellular carcinoma prognosis.
- Being tested
- Serum, plasma and DNA samples, Radiological exploration by CT scan or MRI
- Keywords
- Hepatocellular carcinoma, Cirrhosis, Environmental risk factors, Nutrition, Metabolic syndrome
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum, plasma and DNA samplesBiological
Radiological exploration by CT scan or MRIProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cases: cirrhotic patients with hepatocellular carcinoma | Experimental | Not described Receives: Biological: Serum, plasma and DNA samples; Procedure: Radiological exploration by CT scan or MRI |
| Controls: cirrhotic patients without hepatocellular carcinoma | Active comparator | Not described Receives: Biological: Serum, plasma and DNA samples; Procedure: Radiological exploration by CT scan or MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of the vitamin B12 and the folates
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study start20 Jun 2008
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
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 Cirrhosis With Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798173
- Sponsor's protocol ID
- HILLON HORS AOI 2008
- Acronym
- CIRCE
- Status last verified
- Apr 2022
- First submitted
- 4 Jan 2013
- Last updated
- 21 Apr 2022
- Results posted
- No
Publications
Rizk M, Roux-Levy C, Bernard-Chabert B, Bronowicki JP, Richou C, Habersetzer F, Jouve JL, Hebert JR, Shivappa N, Boutron-Ruault MC, Diab Assaf M, Hillon P, Cottet V; other members of the CirCE Study group. Association between the dietary inflammatory index and the risk of hepatocellular carcinoma in a cirrhotic population. Clin Nutr. 2025 Jan;44:65-75. doi: 10.1016/j.clnu.2024.11.021. Epub 2024 Nov 14.
PubMed 39642746
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRCE: Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT01798173
- Acronym / sponsor ID
- CIRCE / HILLON HORS AOI 2008
- Keywords
- Hepatocellular carcinoma, Cirrhosis, Environmental risk factors, Nutrition, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,246 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Jun 2008 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018
- First posted
- 25 Feb 2013 (estimated)
- 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.
Available data do not allow carcinogenesis mechanisms in cirrhotic patients to be well understood in absence of studies taking into account all recognised factors. A large scale clinical, biochemical and molecular studies is potentially relevant to the understanding of nutrition, physical activity, body weight metabolic syndrome whatever the etiology of underlying cirrhosis. It will open new perspectives :
- in prevention of hepatocellular carcinoma development in cirrhotic patients through dietary counselling and therapeutics of metabolic syndrome,
- in early screening of hepatocellular carcinoma in cirrhotic patients through spectroscopic technology and later proteomic study resulting in an improvement of hepatocellular carcinoma prognosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases: cirrhotic patients with hepatocellular carcinoma | Experimental | Biological: Serum, plasma and DNA samples, Procedure: Radiological exploration by CT scan or MRI |
| Controls: cirrhotic patients without hepatocellular carcinoma | Active comparator | Biological: Serum, plasma and DNA samples, Procedure: Radiological exploration by CT scan or MRI |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Cases and controls will be males and females aged 35 or older, and will give an informed consent to participate in the study.
- Hepatocellular carcinoma case:
- All hepatocellular carcinoma cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. Criteria for the diagnosis of hepatocellular carcinoma will be those defined by the European Association for Study of the Liver (EASL) (Bruix J, J Hepatol 2001):
- alpha-fetoprotein (AFP) < 400 ng/ml: nodules have to be identified by at least two coincident morphologic examinations (abdominal US, angiography, CT or MRI) with arterial hypervascularisation in at least one of the imaging modalities
- AFP > 400 ng/ml: lesion seen in a single imaging modality
Key exclusion criteria (5 listed)
- age under 35 of year
- other cancer in evolution
- HIV infection
- Major somatic pr psychiatric illness not compatible with the inclusion in the study
- No hepatocellular carcinoma primary liver cancer.
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 |
|---|---|---|
| Serum, plasma and DNA samples | Biological | Cases: cirrhotic patients with hepatocellular carcinoma, Controls: cirrhotic patients without hepatocellular carcinoma |
| Radiological exploration by CT scan or MRI | Procedure or surgery | Cases: cirrhotic patients with hepatocellular carcinoma, Controls: cirrhotic patients without hepatocellular carcinoma |
Primary outcome
Dosage of the vitamin B12 and the folates
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Derived from this study: PubMed 39642746Rizk M, Roux-Levy C, Bernard-Chabert B, Bronowicki JP, Richou C, Habersetzer F, Jouve JL, Hebert JR, Shivappa N, Boutron-Ruault MC, Diab Assaf M, Hillon P, Cottet V; other members of the CirCE Study group. Association between the dietary inflammatory index and the risk of hepatocellular carcinoma in a cirrhotic population. Clin Nutr. 2025 Jan;44:65-75. doi: 10.1016/j.clnu.2024.11.021. Epub 2024 Nov 14.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum, plasma and DNA samples and Radiological exploration by CT scan or MRI in people with Cirrhosis With Hepatocellular Carcinoma and Cirrhosis Without Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire Dijon at 6 sites 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 18 inclusion and 5 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: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of the vitamin B12 and the folates (time frame: Baseline). 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 NCT01798173, 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 21 Apr 2022.