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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02623-42 | Other Identifier | IDRCB |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal self sampling detecting HPV | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal self sampling detecting HPV | Procedure | IMIDs patients who are not up to date with CCS be included into the study to perform a vaginal self-screening (VSS) A positive VSS will be confirmed by a standard HPV test and management of the results of standard HPV test or VSS will be performed as planned following HAS guidelines. For women with a positive VSS, follow-up results (HPV test and cytology, biopsy, etc.) will be collected according to the usual procedures of the screening facility and in accordance with the recommendations of the Health authorities |
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of HPV infection (yes/no) after VSS proposal | at one year |
| Measure | Description | Time Frame |
|---|---|---|
| the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population | at inclusion and at one year after inclusion | |
| The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population | at inclusion and at one year after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of HPV infection during follow-up (yes/no) | at inclusion and at one year | |
| description of demographic factor | at inclusion and at one year | |
| description of clinical factor |
Inclusion Criteria:
Prospective and retrospective patient
Retrospective patient
- Patient who underwent Pap smear screening less than one year before the start of the study
Exclusion Criteria:
Prospective and retrospective patient
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| Name | Affiliation | Role |
|---|---|---|
| Tiphaine Goulenok, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Médecine Interne - Hôpital Bichat Claude Bernard | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39325123 | Derived | Goulenok T, Sacre K. HPV Infection and Prevention in Patients With Immune-Mediated Inflammatory Diseases: A Scoping Review. J Clin Rheumatol. 2024 Oct 1;30(7S Suppl 1):S34-S41. doi: 10.1097/RHU.0000000000002122. |
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|
| at inclusion and at one year |
| description of biological factor | at inclusion and at one year |
| description of treatment (corticoids, immunosuppressive treatments) | at inclusion and at one year |
| description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). | at inclusion and at one year |
| description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). | at inclusion and at one year |
| description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). | at inclusion and at one year |
| description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). | at inclusion and at one year |
| Up-to-date cervical cancer screening rate in accordance with HAS recommendations | at 12 months post-inclusion. |
| Proportion of cervical cytological abnormalities if performed (histological confirmation if available) | during 1 year of follow-up |
| proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) | during 1 year of follow-up |
| presence of cervical precancerous lesions and cervical cancer | authenticated on cervico-vaginal smear, if performed (histological confirmation if available) | during 1 year of follow-up |
| HPV vaccination coverage rate | (measured on initial self-questionnaire) | at inclusion |
| Persistence of HPV infection | Prevalence of HR-HPV(s) at second screening , in the case of initial positivity | at one year |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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