Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 4, 2024
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how effective vaginal self-sampling is for detecting high-risk Human Papillomavirus (HPV) infections in women who have certain immune-mediated inflammatory diseases (IMIDs). These diseases include conditions like lupus and scleroderma. The researchers want to find out how common HPV infections are in these patients and how well they can clear the infection over a year. They will also look at the types of HPV present and whether there are any pre-cancerous changes in the cervix.
To participate in this study, women aged 30 to 65 who have one of the specified IMIDs and are not up to date with their cervical cancer screenings may be eligible. Participants will complete a vaginal self-sampling procedure and will have follow-ups to assess their HPV status and overall health. The trial aims to make HPV screening more accessible and acceptable for women with these serious health conditions. If you're considering joining the study, you'll be helping researchers learn more about HPV infections and improve screening methods for women like you.
Gender
FEMALE
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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, France
Patients applied
Trial Officials
Tiphaine Goulenok, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported