<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of Children with IBD (Inflammatory Bowel Disease)</titl>
      <IDNo>FRESH-PEF60126-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="" role=""></producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of Children with IBD (Inflammatory Bowel Disease)            </titl>
      <altTitl>
                    PAEDIATRIC IBD (MICI PEDIATRIQUE)                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF60126-en            </IDNo>
      <IDNo agency="PEF">
                    60126                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF60126                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Jean-Frédéric COLOMBEL                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)">
        <ExtLink title="ROR" URI="https://ror.org/02ppyfa04" role="organisation id"/>
        <ExtLink title="SIREN" URI="265906719" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="Other related cohorts: some general population paediatric cohorts, particularly in Scandinavia and Scotland." type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE (CHU)" email="jean-frederic.colombel@chru-lille.fr">
                    Jean-Frédéric;COLOMBEL
                                            <ExtLink title="ROR" URI="https://ror.org/02ppyfa04" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="265906719" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    inflammatory diease</keyword>
      <keyword vocab="" vocabURI="">
                    hospitalisation</keyword>
      <keyword vocab="" vocabURI="">
                    treatment</keyword>
      <keyword vocab="" vocabURI="">
                    complications</keyword>
      <keyword vocab="" vocabURI="">
                    death</keyword>
      <topcClas vocab="health theme">
                        Clinical immunology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7a3cf568-46ba-4840-be8f-f22fc030139f"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000486"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">To study the correlations between phenotypic peculiarities in patients (onset of IBD, disease progression, treatment response), ASCA and ANCA serological markers and allelic status of NOD2/CARD15 gene. Secondary objectives: - to analyse therapeutic management and surgical predictors for each UC and CD group; - to investigate the development of paediatric forms in adulthood in terms of growth (Z score) and socio-professional level (level of education, age and category of last diploma, current profession); - to establish a database to evaluate the impact of other genetic polymorphisms in order to investigate possible epistasis of these polymorphisms with CARD15/NOD2.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="1988-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant, Newborn (birth to 28 days)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007231"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant (28 days to 2 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007223"/>
                                                    </universe>
      <universe level="age" clusion="I">Child, Preschool (2 to 5 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002675"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe clusion="I">The cohort consists of children with certain or probable Crohn's Disease (CD) or certain or probable ulcerative colitis (UC) identified in the EPIMAD registry between 1988 and 2002.  Children: under 17 years old at the time of diagnosis                    </universe>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Consistency request upon entering computer data and following collection of computer data. Management of missing data by returning to source file and/or returning to general practitioner. Physician reminder for follow-up visits. Internal quality audit carried out once a year. Patients are informed about the use of their data.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>698</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>To be decided if data may be used by academic teams: comparison and validation of data with other IBD cohorts (USA, Norway). Data may not be used by industrial teams.</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
