RecruitingNot ApplicableNCT04901351

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

Feasibility of a Multi-site Screening Strategy in HPV+ Patients at High Risk of Cancer, With Characterization of the HPV Subtypes Involved by High Throughput Sequencing Technique: DEP-HPV

Sponsor

University Hospital, Toulouse

Enrollment

30 participants

Start Date

Jun 21, 2022

Study Type

INTERVENTIONAL

Conditions

Human Papillomavirus

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses advanced genetic sequencing technology to screen for multiple types of high-risk HPV (human papillomavirus) in women who have had persistent or recurring HPV-related cervical or vaginal abnormalities. The goal is to better identify which HPV strains are present. **You may be eligible if...** - You have a persistent high-risk HPV infection lasting at least 6 months after treatment for a cervical or vaginal abnormality - You have had a recurrence of a high-grade cervical lesion (CIN2, CIN3, or HSIL) or a recurrence of cervical or vaginal cancer - You have given written consent to participate - You are covered by social security in France **You may NOT be eligible if...** - Your HPV infection involves only low-risk HPV strains (not the high-risk types linked to cancer) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESmear

In addition to the routine gynecological follow-up including a cervico-vaginal smear and an HPV test (HPV-HR genome detection), the doctor will propose prospectively to all consecutive patients who meet the inclusion criteria, during a follow-up consultation (post treatment of cervical dysplasia), to participate in the study, that is to have 2 other anal and ENT samples for an HPV test