Clinical trial NCT06302725: Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
Official title: Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Infection
Systemic Disease
Keywords: HPV
systemic disease
cervical cancer screening
vaginal self sampling
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility criteria: 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)

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

Primary outcomes:
measure: prevalence of HPV infection (yes/no) after VSS proposal
timeFrame: at one year
Secondary outcomes:
measure: the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population
timeFrame: at inclusion and at one year after inclusion
measure: The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population
timeFrame: at inclusion and at one year after inclusion
Other outcomes:
measure: Presence of HPV infection during follow-up (yes/no)
timeFrame: at inclusion and at one year
measure: description of demographic factor
timeFrame: at inclusion and at one year
measure: description of clinical factor
timeFrame: at inclusion and at one year
measure: description of biological factor
timeFrame: at inclusion and at one year
measure: description of treatment (corticoids, immunosuppressive treatments)
timeFrame: at inclusion and at one year
measure: description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).
timeFrame: at inclusion and at one year
measure: description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).
timeFrame: at inclusion and at one year
measure: description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).
timeFrame: at inclusion and at one year
measure: description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).
timeFrame: at inclusion and at one year
measure: Up-to-date cervical cancer screening rate in accordance with HAS recommendations
timeFrame: at 12 months post-inclusion.
measure: Proportion of cervical cytological abnormalities if performed (histological confirmation if available)
timeFrame: during 1 year of follow-up
measure: proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available)
timeFrame: during 1 year of follow-up
measure: presence of cervical precancerous lesions and cervical cancer
timeFrame: during 1 year of follow-up
measure: HPV vaccination coverage rate
timeFrame: at inclusion
measure: Persistence of HPV infection
timeFrame: at one year
Locations:
city: Paris
country: France
facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Tiphaine Goulenok, MD
role: PRINCIPAL_INVESTIGATOR
References: