Vaginal self-sampling to detect HPV in women with immune-mediated inflammatory diseases
Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
This study is testing if vaginal self-sampling can help women aged 30 to 65 with immune-related diseases find out if they have high-risk HPV infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06302725 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of high-risk Human Papillomavirus (HPV) infections in women aged 30 to 65 with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling. The primary objective is to determine the presence of HPV infection one year after the introduction of self-sampling. Secondary objectives include analyzing HPV types, co-infection rates, factors associated with HPV presence, and the rate of HPV clearance over time. The study will also evaluate the acceptability and tolerance of the self-sampling method among participants.
Who should consider this trial
Good fit: Ideal candidates are women aged 30 to 65 with specific immune-mediated inflammatory diseases who are not up to date with cervical cancer screening.
Not a fit: Patients who have undergone colpohysterectomy or are under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cervical cancer screening practices for women with immune-mediated inflammatory diseases.
How similar studies have performed: Other studies have shown promise in using self-sampling methods for HPV detection, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Service de Médecine Interne - Hôpital Bichat Claude Bernard — Paris, France (Recruiting)
Study contacts
- Principal investigator: Tiphaine Goulenok, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Tiphaine Goulenok, MD
- Email: tiphaine.goulenok@aphp.fr
- Phone: 0140257289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.