Groupe Hospitalier Paris Saint-Joseph
Paris, 75014, France
Location status: Recruiting
Location contact
Helene BEAUSSIER, PharmD, PhD
CONTACT
NCT Number: NCT05566106
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Paris, 75014, France
Location status: Recruiting
Helene BEAUSSIER, PharmD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Fondation Hôpital Saint-Joseph
Other
Acronym: Cohorte_HPV
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