Hepatocellular CarcinomaCIRCE ProSpecNCT01904942
Study of Hepatocellular Carcinoma in Cirrhotic Patients
An observational study of Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire Dijon.
Trial summary
The project is based on a case-control study including cirrhotic patients with (200 cases) and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in proteomic or spectroscopic studies has to be adapted to the high dimensional setting. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jun 2010
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient
Who may be able to join
- Cases and controls will be males aged 35 or older, and will give an informed consent to participate in the study. All HCC cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. Criteria for the diagnosis of HCC will be those defined by the European Association for Study of the Liver (EASL) (Bruix J, J Hepatol 2001): All patients with cirrhosis, whatever its etiology, will be included. The diagnosis of cirrhosis will rely on histological confirmation by liver 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 nails, 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 >18 mm Hg In the present state of knowledge, a fibrotest value at 4 or a fibroscan value > 12,5 kPa Without any other clinical or biological signs will be considered as diagnosis criteria of cirrhosis only for chronic viral C hepatitis. The lack of HCC 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
- - patients under 35years old or more than 75 years of age
- other cancer in evolution
- HIV infection
- major somatic or psychiatric illness not compatible with the inclusion in the study
- non HCC primary liver cancer.
About this study
The project is based on a case-control study including cirrhotic patients with (200 cases) and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in proteomic or spectroscopic studies has to be adapted to the high dimensional setting. The proteomic analysis will be conducted by Clinical Innovation Proteomic Platform of Dijon. Two approaches will be used in the proteomic study: A global approach based on the comparison of proteomic spectra profiles obtained after mass spectrometry analysis (MALDI-TOF). The particularity of this study with regard to previous studies is : the procedures used to purify the sub proteomes (Five automated methods including depletion fractionation and purification will be applied), the qualification of the generated data with the introduction of quality controls, the high number of samples included in the study. The second approach BIA-MS (Biomolecular interaction analysis mass spectrometry) is targeted approach allows the capture, quantification and characterization of proteins.
The quality controls allow to quantify the various variability sources and to validate that biological variability is higher than technical variability. All the samples will be treated and analyzed with the same protocols, 100 samples will be used to validate the marker and statistical models developed after analysis of the first 500 samples. The infra-red spectroscopy analysis will be conducted by MéDIAN team, CNRS UMR 6237 of Reims university. The first 300 samples after feature selection reference spectra, are classified into different classes by means of mathematical classification methods such as multivariate statistical processes of pattern recognition, neuronal networks, support vector machines and methods of case-based classification or machine learning, genetic algorithms or methods of evolutionary programming. The analysis of a second set of samples (300) will validate the different mathematical classification methods developed.
In the global study the investigators will unravel the relationship between proteomic, spectroscopic and metabolic/nutritional data. The description of these relationships will use canonical analysis and multi-block analysis in a more general extent. The goal of these methods is to explore relationships that may exist between several groups of quantitative variables observed on the same set of individuals.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic investigations
Measured: at the baseline
Secondary outcomes (1)
Infrared spectroscopic investigations
Measured: at the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startOct 2008
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DUCOROY Patrick, Principal investigator, Pole de recherche clinique / CLIPP (Clinical Innovation ProteomicPlatform)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904942
- Sponsor's protocol ID
- DUCOROY PHRC K 2010
- Acronym
- CIRCE ProSpec
- Status last verified
- Jul 2013
- First submitted
- 26 Jun 2013
- Last updated
- 22 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hepatocellular Carcinoma in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT01904942
- Acronym / sponsor ID
- CIRCE ProSpec / DUCOROY PHRC K 2010
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2010 (actual)
- First posted
- 22 Jul 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.
The project is based on a case-control study including cirrhotic patients with (200 cases) and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in proteomic or spectroscopic studies has to be adapted to the high dimensional setting. The proteomic analysis will be conducted by Clinical Innovation Proteomic Platform of Dijon. Two approaches will be used in the proteomic study: A global approach based on the comparison of proteomic spectra profiles obtained after mass spectrometry analysis (MALDI-TOF). The particularity of this study with regard to previous studies is : the procedures used to purify the sub proteomes (Five automated methods including depletion fractionation and purification will be applied), the qualification of the generated data with the introduction of quality controls, the high number of samples included in the study. The second approach BIA-MS (Biomolecular interaction analysis mass spectrometry) is targeted approach allows the capture, quantification and characterization of proteins.
The quality controls allow to quantify the various variability sources and to validate that biological variability is higher than technical variability. All the samples will be treated and analyzed with the same protocols, 100 samples will be used to validate the marker and statistical models developed after analysis of the first 500 samples. The infra-red spectroscopy analysis will be conducted by MéDIAN team, CNRS UMR 6237 of Reims university. The first 300 samples after feature selection reference spectra, are classified into different classes by means of mathematical classification methods such as multivariate statistical processes of pattern recognition, neuronal networks, support vector machines and methods of case-based classification or machine learning, genetic algorithms or methods of evolutionary programming. The analysis of a second set of samples (300) will validate the different mathematical classification methods developed.
In the global study the investigators will unravel the relationship between proteomic, spectroscopic and metabolic/nutritional data. The description of these relationships will use canonical analysis and multi-block analysis in a more general extent. The goal of these methods is to explore relationships that may exist between several groups of quantitative variables observed on the same set of individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient
Key inclusion criteria (6 listed)
- Cases and controls will be males aged 35 or older, and will give an informed consent to participate in the study. All HCC cases evolving in cirrhotic liver, whatever the etiology of cirrhosis, will be included. Criteria for the diagnosis of HCC will be those defined by the European Association for Study of the Liver (EASL) (Bruix J, J Hepatol 2001): All patients with cirrhosis, whatever its etiology, will be included. The diagnosis of cirrhosis will rely on histological confirmation by liver 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:
Key exclusion criteria (5 listed)
- - patients under 35years old or more than 75 years of age
- other cancer in evolution
- HIV infection
- major somatic or psychiatric illness not compatible with the inclusion in the study
- non HCC 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.
Primary outcome
Proteomic investigations
Time frame: at the baseline
1 secondary outcome
Infrared spectroscopic investigations
Time frame: at the 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 22 Jul 2013.
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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.
DUCOROY Patrick principal investigator
Pole de recherche clinique / CLIPP (Clinical Innovation ProteomicPlatform)
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire Dijon.
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 6 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 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Proteomic investigations (time frame: at the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2013.