Monitoring anal health in women with a history of high-grade HPV lesions
Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV
This study is trying to see if regular check-ups can help women with a history of high-grade HPV lesions catch any signs of anal cancer early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondation Hôpital Saint-Joseph Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05566106 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women aged 18 and older who have a history of high-grade HPV-induced gynecological lesions. It aims to monitor these patients through a proctology follow-up protocol to assess the potential development of anal cancer, which is significantly linked to HPV. The study seeks to gather data on the incidence of anal lesions and improve early diagnosis, thereby potentially reducing the risk of anal cancer. Participants must be French-speaking and consent to the use of their data for research purposes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a history of high-grade HPV-induced gynecological lesions who are participating in proctology follow-up.
Not a fit: Patients with a history of induced high-grade anal HPV lesions or those under legal guardianship may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for anal cancer in women with a history of HPV-related lesions.
How similar studies have performed: While there is limited data on similar studies, the focus on early diagnosis of anal lesions in HPV-infected populations is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient whose age ≥ 18 years * Patient with a high-grade or higher HPV-induced gynecological lesion * Patient participating in the proctology follow-up protocol * French-speaking patient Exclusion Criteria: * Patient with a history of induced high-grade anal HPV lesion and above * Patient under guardianship or curatorship * Patient deprived of liberty * Patient under court protection * Patient objecting to the use of his/her data for this research
Where this trial is running
Paris
- Groupe Hospitalier Paris Saint-Joseph — Paris, France (Recruiting)
Study contacts
- Principal investigator: Sophie Wylomanski, MD — Fondation Hôpital Saint-Joseph
- Study coordinator: Sophie Wylomanski, MD
- Email: swylomanski@ghpsj.fr
- Phone: 144127173
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.