nctId: NCT06302725 id: APHP231514 id: 2023-A02623-42 type: OTHER domain: IDRCB briefTitle: Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases acronym: APOSY overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2027-03 date: 2024-03-12 date: 2024-03-12 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity). conditions: HPV Infection conditions: Systemic Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Vaginal self sampling detecting HPV measure: prevalence of HPV infection (yes/no) after VSS proposal measure: the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population measure: The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population measure: Presence of HPV infection during follow-up (yes/no) measure: description of demographic factor measure: description of clinical factor measure: description of biological factor measure: description of treatment (corticoids, immunosuppressive treatments) measure: description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). measure: Up-to-date cervical cancer screening rate in accordance with HAS recommendations measure: Proportion of cervical cytological abnormalities if performed (histological confirmation if available) measure: proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) measure: presence of cervical precancerous lesions and cervical cancer measure: HPV vaccination coverage rate measure: Persistence of HPV infection sex: FEMALE minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard city: Paris zip: 75018 country: France name: Tiphaine Goulenok, MD role: CONTACT phone: 00 33 1 40 25 72 89 email: tiphaine.goulenok@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False