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

NCT06302725 | Active Not Recruiting

• 2 other identifiers: APHP2315142023-A02623-42
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Systemic Disease; HPV Infection

Keywords

HPV; systemic disease; cervical cancer screening; vaginal self sampling

Outcome Measures

Primary Outcomes (1)

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

  at one year

Secondary Outcomes (2)

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

  at inclusion and at one year after inclusion

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

  at inclusion and at one year after inclusion

Other Outcomes (15)

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

  at inclusion and at one year

• description of demographic factor

  at inclusion and at one year

• description of clinical factor

  at inclusion and at one year

Study Arms (1)

Vaginal self sampling detecting HPV

EXPERIMENTAL

Procedure: Vaginal self sampling detecting HPV

Interventions

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

Vaginal self sampling detecting HPV

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Interne - Hôpital Bichat Claude Bernard

Paris, 75018, France

Location

Related Publications (1)

• Goulenok T, Sacre K. HPV Infection and Prevention in Patients With Immune-Mediated Inflammatory Diseases: A Scoping Review. J Clin Rheumatol. 2024 Oct 1;30(7S Suppl 1):S34-S41. doi: 10.1097/RHU.0000000000002122.

  PMID: 39325123 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiphaine Goulenok, MD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)