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<docDscr>
  <citation>
    <titlStmt>
      <titl>Enteric Neuropathy</titl>
      <IDNo>FRESH-PEF5972-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Arnaud BOURREILLE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Enteric Neuropathy            </titl>
      <altTitl>
                    NEUROPATHIE ENTERIQUE (ENTERIC NEUROPATHY)                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF5972-en            </IDNo>
      <IDNo agency="PEF">
                    5972                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF5972                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Arnaud BOURREILLE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="bp-cic-imad@chu-nantes.fr">
                    Arnaud;BOURREILLE
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    phenotypic data</keyword>
      <keyword vocab="" vocabURI="">
                    demographic data</keyword>
      <keyword vocab="" vocabURI="">
                    computerised data bank</keyword>
      <keyword vocab="" vocabURI="">
                    biotherapy</keyword>
      <keyword vocab="" vocabURI="">
                    steroid dependence</keyword>
      <keyword vocab="" vocabURI="">
                    rheumatic</keyword>
      <keyword vocab="" vocabURI="">
                    skin</keyword>
      <keyword vocab="" vocabURI="">
                    eye and vascular extra-digestive symptoms</keyword>
      <keyword vocab="" vocabURI="">
                    hospital stays</keyword>
      <keyword vocab="" vocabURI="">
                    immunosuppressants</keyword>
      <keyword vocab="" vocabURI="">
                    health events</keyword>
      <keyword vocab="" vocabURI="">
                    consultation</keyword>
      <keyword vocab="" vocabURI="">
                    diagnosis</keyword>
      <keyword vocab="" vocabURI="">
                    surgery</keyword>
      <keyword vocab="" vocabURI="">
                    liver</keyword>
      <topcClas vocab="health theme">
                        Neurology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009462"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Gastroenterology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/a3898340-a42d-4f5e-a822-1de204a9a867"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D005762"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Mitochondrial myopathies                                            </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">General objective: to develop and expand the cohort and enteric neuropathy biological collection for patients with IBD and Parkinson's disease (PD). Secondary objectives: - Transcriptomic study of neuronal and glial plasticity; - Study and classification of neuro-degenerative processes; - Correlation of neuronal damage with clinical parameters and outlook.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2009-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Pays de la Loire</geogCover>
      <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">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe clusion="I">Enrolment includes all adult patients with IBD and PD monitored by the CHU in Nantes. Patients will be enrolled at time of diagnosis. Patients will be enrolled after disease diagnosis if phenotypic data included in the database are available in the source file. Blood will be taken during sampling in order to monitor patient disease. Biopsy samples will be taken during endoscopic examinations for conventional disease monitoring.                     </universe>
      <universe clusion="E">underage patients, absence of study participation consent, lost to follow-up, phenotypic data not available from source file, PD patients with no digestive disorder requiring an endoscopy.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>Consistency request after electronic data is recorded. Missing data is managed by returning to source file. Physician reminder for follow-up visits. Subject reminder for follow-up visits. Annual internal quality audit of database with 10% file analysis. 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>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 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>100 IBD patients and 30 PD patients were included in the biological collection. These patients are part of the historical cohort. Phenotypic data is entered in the electronic database.</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Data may be used by academic teams. Data may be used by industrial teams.</restrctn>
      <conditions>Access conditions for biological collection are part of the Biobanque Ouest Atlantique (BOA, Western Atlantic Biobank) pending GIS-IBiSA certification request. Data will be available to other institutional research teams under contract. Data will be available to other private research teams under contract with CHU.</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
