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

April 14, 2022 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • Hôpital Jean Minjoz
      • Dijon, France, 21079
        • Hôpital du Bocage
      • Metz, France, 57038
        • Centre Hospitalier de METZ
      • Reims, France, 51092
        • CHU Robert Debré
      • Strasbourg, France, 67091
        • Clinique médicale B. Hôpital Civil-Hôpitaux Universitaires
      • Vandoeuvre-les-nancy, France, 54511
        • Hôpital de Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cases: cirrhotic patients with hepatocellular carcinoma
Biological: Serum, plasma and DNA samples
Procedure: Radiological exploration by CT scan or MRI
ACTIVE_COMPARATOR: Controls: cirrhotic patients without hepatocellular carcinoma
Biological: Serum, plasma and DNA samples
Procedure: Radiological exploration by CT scan or MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dosage of the vitamin B12 and the folates
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2008

Primary Completion (ACTUAL)

January 25, 2018

Study Completion

January 25, 2018

Study Registration Dates

First Submitted

January 4, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (ESTIMATE)

February 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HILLON HORS AOI 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cirrhosis With Hepatocellular Carcinoma

Clinical Trials on Serum, plasma and DNA samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe