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

HPV Infection Clinical Trial

— APOSY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302725
• Other study ID #: APHP231514
• Secondary ID: 2023-A02623-42
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 2027

Study information

• Verified date: June 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Tiphaine Goulenok, MD
• Phone: 0140257289
• Email: tiphaine.goulenok[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HPV Infection
• Infections
• Papillomavirus Infections
• Systemic Disease

Intervention

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

Locations

Country	Name	City	State
France	Service de Médecine Interne - Hôpital Bichat Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of HPV infection during follow-up (yes/no)		at inclusion and at one year
Other	description of demographic factor		at inclusion and at one year
Other	description of clinical factor		at inclusion and at one year
Other	description of biological factor		at inclusion and at one year
Other	description of treatment (corticoids, immunosuppressive treatments)		at inclusion and at one year
Other	description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
Other	description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
Other	description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
Other	description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
Other	Up-to-date cervical cancer screening rate in accordance with HAS recommendations		at 12 months post-inclusion.
Other	Proportion of cervical cytological abnormalities if performed (histological confirmation if available)		during 1 year of follow-up
Other	proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available)		during 1 year of follow-up
Other	presence of cervical precancerous lesions and cervical cancer	authenticated on cervico-vaginal smear, if performed (histological confirmation if available)	during 1 year of follow-up
Other	HPV vaccination coverage rate	(measured on initial self-questionnaire)	at inclusion
Other	Persistence of HPV infection	Prevalence of HR-HPV(s) at second screening , in the case of initial positivity	at one year
Primary	prevalence of HPV infection (yes/no) after VSS proposal		at one year
Secondary	the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population		at inclusion and at one year after inclusion
Secondary	The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population		at inclusion and at one year after inclusion