Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases

Not Applicable

Recruiting

• Conditions: HPV Infection; Systemic Disease
• Interventions: Procedure: Vaginal self sampling detecting HPV

• Registration Number: NCT06302725
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 (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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2026-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Women aged 30 to 65 years old
• presenting with MSIA, MSIA includes Systemic lupus erythematosus Sjögren's syndrome Systemic scleroderma Mixed connective tissue disease Inflammatory myositis Systemic sarcoidosis Systemic vasculitis Behçet's disease Adult-onset Still's disease IgG4-related disease Autoimmune cytopenia (autoimmune hemolytic anemia, immune thrombocytopenic purpura, Evans syndrome) Susac syndrome
• Followed in the internal medicine department of Bichat Hospital, Paris
• At least 1 scheduled visit between December 2023 and December 2025
• Not up to date with gynecological follow-up (i.e., cervical cancer screening more than one year old or undatable)

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Exclusion Criteria

• Patient under legal protection, guardianship, or trusteeship
• History of colpohysterectomy
• Not affiliated with a social security scheme (general or CMU)
• Absence of informed and written consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal self sampling detecting HPV	Vaginal self sampling detecting HPV	-

Primary Outcome Measures

Name	Time	Method
prevalence of HPV infection (yes/no) after VSS proposal	at one year

Secondary Outcome Measures

Name	Time	Method
The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population	at inclusion and at one year after inclusion
the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population	at inclusion and at one year after inclusion

Trial Locations

Locations (1)

Service de Médecine Interne - Hôpital Bichat Claude Bernard; 🇫🇷 Paris, France