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Recruiting NCT04901351

Multi-site HPV Screening by High-throughput Sequencing in Patients With Chronic HPV-HR Infection Followed by Gynecology

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Trial Parameters

Condition Human Papillomavirus
Sponsor University Hospital, Toulouse
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2022-06-21
Completion 2025-06
Interventions
Smear

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Brief Summary

The main risk of developing cervical cancer is the persistence of an High risk human papillomavirus (HPV-HR) infection, the mechanisms of which are still not understood. These chronically infected patients could develop multi-site lesions. The main objective is to assess the feasibility of setting up a personalized screening in patients at high risk of cervical cancer (chronically infected with HPV), by evaluating documenting the acceptability of these patients to be sampled from the ENT sphere and anal spheres for HPV analysis with next-generation sequencing.

Eligibility Criteria

Inclusion Criteria: -Chronic infected patients defined by: Patients with persistent HPV-HR cytological infection (high risk) (as early as 6 months post-treatment of a cervical or vaginal injury), or a recurrence of a high-grade squamous intraepithelial lesion (CIN2 or CIN3 or HSIL) or a recurrence of cancer in the cervix or vagina * Patients who have given their written consent to participate in the study. * Person affiliated or beneficiary of a social security scheme. Exclusion Criteria: Patient with an infection or a persistent lesion after treatment or not, linked only to low-risk HPV.

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