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Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients (CIRCE)

Primary Purpose

Cirrhosis With Hepatocellular Carcinoma, Cirrhosis Without Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serum, plasma and DNA samples
Radiological exploration by CT scan or MRI
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis With Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Cirrhosis, Environmental risk factors, Nutrition, Metabolic syndrome

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hôpital Jean Minjoz
  • Hôpital du Bocage
  • Centre Hospitalier de METZ
  • CHU Robert DEBRE
  • Clinique médicale B. Hôpital Civil-Hôpitaux Universitaires
  • Hôpital de BRABOIS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cases: cirrhotic patients with hepatocellular carcinoma

Controls: cirrhotic patients without hepatocellular carcinoma

Arm Description

Outcomes

Primary Outcome Measures

Dosage of the vitamin B12 and the folates

Secondary Outcome Measures

Full Information

First Posted
January 4, 2013
Last Updated
April 14, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT01798173
Brief Title
Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
Acronym
CIRCE
Official Title
CIRCE: Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2008 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
January 25, 2018 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis With Hepatocellular Carcinoma, Cirrhosis Without Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Cirrhosis, Environmental risk factors, Nutrition, Metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cases: cirrhotic patients with hepatocellular carcinoma
Arm Type
Experimental
Arm Title
Controls: cirrhotic patients without hepatocellular carcinoma
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Serum, plasma and DNA samples
Intervention Type
Procedure
Intervention Name(s)
Radiological exploration by CT scan or MRI
Primary Outcome Measure Information:
Title
Dosage of the vitamin B12 and the folates
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Hôpital Jean Minjoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Hôpital du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier de METZ
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
CHU Robert DEBRE
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Clinique médicale B. Hôpital Civil-Hôpitaux Universitaires
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital de BRABOIS
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

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Environmental, Metabolic and Nutritional Factors of Hepatocellular Carcinoma in Cirrhotic Patients

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