Skip to main content
OpenTrials
Completed

NCT Number: NCT06302725

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Interne - Hôpital Bichat Claude Bernard

Paris, 75018, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Prospective and retrospective patient

  • 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
  • Not up to date with gynecological follow-up (i.e., Pap smear more than one year old or undatable) (for retrospective patients: at the time of initial screening)

Retrospective patient

  • Patient who underwent Pap smear screening less than one year before the start of the study

Exclusion criteria

Prospective and retrospective patient

  • 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

Treatment and study plan

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

Primary outcomes

  1. prevalence of HPV infection (yes/no) after VSS proposal

    Time frame: at one year

Secondary outcomes

  1. the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population

    Time frame: at inclusion and at one year after inclusion

  2. The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population

    Time frame: at inclusion and at one year after inclusion

Other outcomes

  1. Presence of HPV infection during follow-up (yes/no)

    Time frame: at inclusion and at one year

  2. description of demographic factor

    Time frame: at inclusion and at one year

  3. description of clinical factor

    Time frame: at inclusion and at one year

  4. description of biological factor

    Time frame: at inclusion and at one year

  5. description of treatment (corticoids, immunosuppressive treatments)

    Time frame: at inclusion and at one year

  6. description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).

    Time frame: at inclusion and at one year

  7. description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).

    Time frame: at inclusion and at one year

  8. description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).

    Time frame: at inclusion and at one year

  9. description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).

    Time frame: at inclusion and at one year

  10. Up-to-date cervical cancer screening rate in accordance with HAS recommendations

    Time frame: at 12 months post-inclusion.

  11. Proportion of cervical cytological abnormalities if performed (histological confirmation if available)

    Time frame: during 1 year of follow-up

  12. proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available)

    Time frame: during 1 year of follow-up

  13. presence of cervical precancerous lesions and cervical cancer

    Time frame: during 1 year of follow-up

    authenticated on cervico-vaginal smear, if performed (histological confirmation if available)

  14. HPV vaccination coverage rate

    Time frame: at inclusion

    (measured on initial self-questionnaire)

  15. Persistence of HPV infection

    Time frame: at one year

    Prevalence of HR-HPV(s) at second screening , in the case of initial positivity

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: APOSY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.