Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV

Recruiting

• Conditions: Human Papilloma Virus

• Registration Number: NCT05566106
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

Human Papillomavirus (HPV) infection is the most common sexually transmitted infection in the world. It is currently estimated that 4.5% of all cancers worldwide are attributable to HPV, representing 630,000 new cases per year. HPV is responsible for more than 98% of pre-cancerous and cancerous lesions of the cervix and vagina and 88% of anal cancers.

Although prevention of HPV infection has been available since 2007, there are approximately 3000 new cases of cervical cancer in France each year. Women benefit from organized screening for cervical cancer.

HPV is also responsible for anal cancer in more than 90% of cases, mostly caused by HPV 16/18. Its incidence is lower with 1162 cases in women in 2018 but is increasing strongly (+88% in women since 1990).

As with cervical cancer, there are precursors to anal cancer: high-grade intraepithelial lesions. Early diagnosis of these lesions could potentially reduce the incidence of anal cancer, but there are still few data in the literature. The prevalence of anal carriage in patients with a history of cervical dysplasia or cervical cancer is estimated in studies to be 20% with a risk of high grade anal lesions of 8%.

The relative risk of developing anal cancer in women with a history of high-grade cervical lesions is about 5 per 100,000, 15 per 100,000 for those with a history of cervical cancer, and 42 and 48 per 100,000 respectively for women with HPV-induced pre-cancer and cancerous lesions of the vulva.

The different means of cervico-vaginal screening: screening samples: HPV test, cytology, some biomarkers: double labelling p16/ki67, E6-E7 mRNA and clinical examination with or without colposcopy (examination of the cervix with a magnifying glass) are used at the gynecological level but also at the anal level with as examination: simple anuscopy and high resolution anuscopy. Some scientific societies have established surveillance algorithms for certain risk groups, but there are no clinical practice recommendations yet for women with a history of gynecological HPV-induced lesions.

A proctology follow-up protocol for at-risk patients is proposed to patients based on cervico-vaginal surveillance recommendations and data in the literature, pending clinical practice guidelines. The frequency of these examinations depends on the patient's age and the existence of other risk factors for the development of anal HPV lesions. Depending on these elements, follow-up is proposed every 3 years, 5 years, or annually.

The objective of this work is therefore to propose proctological surveillance to this population considered at risk, according to age, smear results and HPV test.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-22
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Last Update Submitted: 2022-10-04
• Last Update Posted: 2022-10-06
• Primary Completion: 2032-08-01
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of developing HPV-induced lesions	Year1	This outcome corresponds to the number of HPV-induced lesions detected at the anal level according to the proctological follow-up protocol.

Secondary Outcome Measures

Name	Time	Method
Model for screening and anal follow-up in patients with a history of gynecologic high-grade HPV-induced lesions	Year 1	This outcome corresponds to the comparison of time to onset of anal HPV-induced lesions in the study population at follow-up during the study period.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France