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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of High-Grade AIN3 Anal Dysplasia</titl>
      <IDNo>FRESH-PEF8099-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE PARIS CITE" role="">Nathalie GAULT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
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  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of High-Grade AIN3 Anal Dysplasia            </titl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF8099-en            </IDNo>
      <IDNo agency="PEF">
                    8099                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF8099                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Nathalie GAULT                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE PARIS CITE">
        <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
        <ExtLink title="SIREN" URI="130025737" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            LIGUE NATIONALE CONTRE LE CANCER (LNCC)                    
                                    </fundAg>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
      <fundAg>
                                            SANOFI (FRANCE)                    
                                    </fundAg>
      <fundAg>
                                            SIDACTION (ECS)                    
                                    </fundAg>
      <fundAg>
                                            SOCIETE NATIONALE FRANÇAISE DE GASTRO-ENTEROLOGIE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="UNIVERSITE PARIS CITE" email="laurent.abramowitz@aphp.fr">
                    Laurent;ABRAMOWITZ
                                            <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130025737" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE PARIS CITE" email="nathalie.gault@intradef.gouv.fr">
                    Nathalie;GAULT
                                            <ExtLink title="ROR" URI="https://ror.org/05f82e368" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130025737" 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="">
                    High-grade anal dysplasia (AIN3)</keyword>
      <keyword vocab="" vocabURI="">
                    epidermoid carcinoma of the anus</keyword>
      <keyword vocab="" vocabURI="">
                    risk factors</keyword>
      <topcClas vocab="health theme">
                        Oncology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D008495"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </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">
                        Carcinoma in situ of other or unspecified digestive organs                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">The main objective of the study is the evaluation of 3-year anal carcinoma incidence in patients with anal AIN3 lesions. Secondary objectives are: - To identify patients with an anal AIN3 lesion, risk factors (demographical data, HIV status...), treatment factors (type of therapeutic treatment), virological and immunological factors (HPV genotype, presence or non-presence of P16 and Ki67 proteins) associated with the onset of epidermoid carcinoma of the anus.- To identify if the presence of P16/Ki67 factors and high risk HPV virus is associated with an increased risk of recurrent AIN3 lesions and if this is the case for high-grade dysplasia of the cervix. - To estimate the proportion of adherent patients, and to identify factors associated with compliance monitoring (demographics, HIV status, type of treatment undertaken ...) - to assess the overall feeling of patients towards anal AIN3 lesion therapeutic care.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2000-01-01"/>
      <collDate event="end" date="2030-01-01"/>
      <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">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 level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Anal AIN3 lesion diagnosed by histology: - aposteriori for patients with a history of anal AIN3 complicated or not complicated by anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since 1st January 2000. - patients consulting a proctologist at time of diagnosis for first displasic anal AIN3 lesion.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Paraclinical data (non-biological) : Imaging</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>monthly data management</otherQualityStatement>
      <otherQualityStatement>queries on missing data or inconsistencies</otherQualityStatement>
      <otherQualityStatement>median follow-up</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception</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>Physical/biological measurements (blood pressure, weight, biochemistry, imaging, etc.)                                                            <concept vocab="CESSDA" vocabURI="MeasurementsAndTests.Physical"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>865</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <conditions>Contact the principal investigator</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
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<dataDscr>
</dataDscr></codeBook>
