Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302725
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-04
Brief Title:
Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APOSY
Brief Summary:
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 yesno 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 YesNo type or HPV multi-infection more than 2 HPV YesNo 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-HPVs at second screening at one year in the case of initial positivity Persistence of HPV infection YesNo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02623-42 | OTHER | IDRCB | None |