by icia icia

Objectives:
The assessment of NAFLD and GD prevalence and risk factors in a large group of the population (about 10,000 subjects) – represented by hospital population coming from a large geographic area covering many counties from Transylvania – and evaluation of their belonging to the MS;

OBJECTIVES The major objectives of the project are:

  • The assessment of NAFLD and GD prevalence and risk factors in a large group of the population (about 10,000 subjects) – represented by hospital population coming from a large geographic area covering many counties from Transylvania – and evaluation of their belonging to the MS;
  • Identification of non-invasive highly reliable methods for the confirmative diagnosis and staging of NAFLD;
  • Optimization of the imaging diagnosis through mathematical modeling and image processing techniques;
  • Creation of a complete database to enable the affiliation to the great European multicentric networks, within the 7 Framework Program;
  • Implementation and dissemination of the results in the medical practice;
  • Increase of the Romanian research visibility in the perspective of joining the European scientific community and accessing common research projects.

The final purpose of the project: the identification of the risk factors for NAFLD and GD through a vast clinical epidemiology research and the implementation in Romania of non-invasive, performing and accessible means to optimize NAFLD and viral C hepatitis diagnosis, which will reduce costs and increase the efficacy of prophylaxis and therapy. In the same time, the study will identify the pathogenetic links between NAFLD and GD, and, consequently, possibilities of preventive and therapeutic intervention.
DESCRIPTION The goal of the project FINALISM is to estimate the prevalence of non- Detection, diagnosis and monitoring. With emphasis on non-invasive or minimally invasive approaches alcoholic fatty liver disease (NAFLD) and gallstone disease (GD), recently recognized components of the metabolic syndrome (the new pandemia of the modern societies) in a large hospital population (about 10,000 subjects), stratified according to the criteria of clinical epidemiology studies.
The metabolic risk factors for NAFLD and GD will be evaluated in a case-control study, which will allow a thourough analyzis of the clinical, biological and ultrasonographical (by using high-resolution technology) parameters. The applicative research will be followed by a basic research, in order to elucidate the pathogenetic interrelationships between NAFLD and GD (insulin resistance, cytokinic profile, oxydative stress). This will bring new knowledge in a field insufficiently investigated.
The structure of the project and the innovation degree will allow optimizing the diagnostic modalities and the staging of chronic viral C hepatitis and of NAFLD, by implementing non-invasive procedures, by elaborating methods of mathematical remodulation and image processing, as well as by identifying the metabolic component of viral C hepatitis, a major public health problem in Romania. The documentation of cholesterol GD as a component of the metabolic syndrome, only theoretically speculated in the present, would represent a significant original scientific contribution
RESULTS ESTIMATED Measurable objectives:

  • Elaboration of the protocol of a clinical epidemiology study and its implementation, aiming at establishing the prevalence and risk factors for NAFLD and GD;
  • Study of the analysis and processing methods of US images;
  • Comparative analysis of the invasive and biological noninvasive diagnostic and staging methods for NAFLD;
  • Elaboration of a computerized imaging method;
  • Data gathering and data base creation for the epidemiologic study;
  • US investigation with a performing equipment, image acquisition in order to test a new system for evaluation of the hepatic texture;
  • The establishment of a correlation between NAFLD, GD and the definitory parameters of the MS;
  •  A case-control study for evaluating the risk factors for NAFLD and GD;
  • Identification of the pathogenetic mechanisms involved in the development of NAFLD and GD;
  • Documentation of insulin resistance, oxydative stress and cytokinic profile in NAFLD;
  • Patient selection and creation of a sera stock prelevated from the subjects with viral C hepatitis;
  • Validation of mathematical simulation and image processing techniques for the NAFLD confirmative diagnosis and staging, in the context of acknowledged morphopathologic, imaging and non-invasive biologic investigations;
  • Testing on patients of the software modules in the consulting room of the specialist physician;
  • Documentation of insulin resistance, iron overload and LS in chronic viral C hepatitis, as assessed by biological, morphological and virusological parameters;
  • Elaboration of a support for lectures;
  • Presentation of a diagnostic and screening algorithm, elaboration of promotional materials including the partial results;
  • Elaboration of a screening and diagnosis strategy;
  • Optimization and evaluation of the applications software – integrated system;
  • Article publication in indexed journals;
  • Creation of CDs for presentation;
  • Creation of a web page;
  • Presentation and dissemination of the results.
RESULTS OBTAINED Stage I. Applied research:
Stage period: 01.09.2006 – 15.11.2006Obtained results:

  • Clinical study protocol;
  • Biological study protocol;
  • Imagistic study protocol;
  • Morphologic study protocol;
  • Epidemiologic study protocol;
  • Computerized entry system specifications;
  • Study data sheets;
  • A study about the methods of analyzing and processing the ultrasonic images;
  • Setting out the screening on a group of patients.

 

Stage II. Applied research:
Stage period: 16.11.2006 – 30.04.2007

Obtained results:

  • The data base has been completed for the investigation of the invasive and non-invasive biological parameters in order to characterize the NAFLD and to test the imagistic methods that make it possible to differentiate the fibrosis from steatosis and also to determine the stage of the fibrosis;
  • The retrospective study has been conducted on the diagnostic value of the non-invasive biological markers of hepatic fibrosis in chronic viral C hepatitis. Afterwards releasing the results so as to replace the invasive parameters that include hepatic biopsy with non-invasive procedures;
  • The gallbladder motility study has been started;
  • The computerized imagistic methods have been elaborated and the software module has been created;
  • The intermediary rapport of activities that includes the technical-economical feedback of the stage.

 

Stage III. Applied research:
Stage period: 01.05.2007 – 30.10.2007

Obtained results:

  • 5000 patients have been screened using ultrasonic methods so as to identify their metabolic profile;
  • A complex epidemiologic study on the risk factors of NAFLD has been carried out on 3000 cases and one for GD on 1000 cases;
  • The metabolic component of chronic viral hepatitis C has been investigated through complex biological and morphologic determinations;
  • Research related to the pathogenetic mechanism involved in the determination of the NAFLD have been set out (insulin resistance, cytokine profile, oxidative stress);
  • The study regarding the gallbladder motility in GD and Metabolic Syndrome has been continued;
  • Proper ultrasonic images analysis and software modules methods have been implemented;
  • An intermediary activity report has been accomplished, and it includes the technical-economical feedback of the stage.

 

Stage IV. Applied research:
Stage period: 01.11.2007 – 30.05.2008

Obtained results:

  • The screening activity has been continued on 8000 patients through ultrasonic methods in order to identify the metabolic profile;
  • The mathematic modulation and image processing techniques have been validated so as to confirmatively diagnose and stage the NAFLD;
  • The software modules have been elaborated and tested;
  • Statistic work have been elaborated;
  • The metabolic component of the chronic viral C infection has been investigated through complex biological and morphologic determination;
  • Research have been carried out on the pathogenic mechanism involved in the determination of the NAFLD and GD;
  • Insulin resistance, cytokine profile, oxidative stress;
  • The study of the gallbladder motility in GD and MS has been continued;
  • The witness case study has been continued (intermediary processing on a number of 2961 cases);
  • An intermediary activity report has been accomplished and it includes the technical-economical feedback of the stage.

 

Stage V. Coclusions:
Stage period: 01.06.2008 – 10.10.2008

Obtained results:

  • The optimization and evaluation of the software applications;
  • Statistic processing;
  • The determination of the prevalence and the identification of the risk factors for NAFLD and GD through a wide clinic epidemiology study;
  • The finalization of the statistic processing in order to identify the metabolic component of chronic viral C infection (hepatic steatosis, insulin resistance, the disturbance of the iron metabolism with complex morphology, biology, virology and imagistic exploration) – see also the final scientific report;
  • Complex, comparative analysis of the performance of the invasive and non-invasive diagnosis means of investigation in the chronic viral C infection staging diagnosis (see also – final scientific report);
  • Final statistic processing involved in NAFLD determination (insulin resistance, cytokine profile, oxidative stress); see also – final scientific report;
  • Final evaluation for the NAFLD invasive and non-invasive means of diagnosis; see also – final scientific report;
  • The elaboration of the screening and diagnosis strategy for the NAFLD, in collaboration with ISP;
  • Teaching support materials;
  • The recommended screening and diagnosis strategy;
  • Articles and communications;
  • Web page;
  • Presentation CD.
Other Informations Date contact:
CO –  Universitatea de Medicina si Farmacie ” Iuliu Hatieganu”  Cluj-Napoca, UMF Corina Radu: corinaradu1@yahoo.comP3 – INCDO–INOE 2000, filiala Institutul de Cercetari pentru Instrumentatie Analitica Cluj-Napoca, ICIASergiu Cadar: sergiu.cadar@icia.ro
Attached documents:
 Finalism – General information Finalism-Research 1

 Finalism-Research 2

 Finalism-Research 3

 Finalism-Research 4

 Finalism-Research 5

 Finalism-Results