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

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).

Conditions

• HPV Infection
• Systemic Disease

Interventions

PROCEDURE

Vaginal self sampling detecting HPV

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Tiphaine Goulenok, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2026-06-30

Completion

2027-03-31

Countries

• France

Study Locations