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

October 4, 2022 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Recruiting

Conditions

Human Papilloma Virus

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sophie Wylomanski, MD
Phone Number: +33 144127173
Email: swylomanski@ghpsj.fr

Study Contact Backup

Name: Helene BEAUSSIER, MD
Phone Number: +33 144127883
Email: crc@ghpsj.fr

Study Locations

France
- - Paris, France, 75014
    - Recruiting
    - Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient whose age ≥ 18 years, with a high-grade or higher HPV-induced gynecological lesion and participating in the proctology follow-up protocol.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of developing HPV-induced lesions Time Frame: Year1	This outcome corresponds to the number of HPV-induced lesions detected at the anal level according to the proctological follow-up protocol.	Year1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Model for screening and anal follow-up in patients with a history of gynecologic high-grade HPV-induced lesions Time Frame: 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.	Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

Principal Investigator: Sophie Wylomanski, MD, Groupe Hospitalier Paris Saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Anticipated)

August 1, 2032

Study Completion (Anticipated)

December 31, 2032

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria