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

NCT04901351 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-19

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus

Interventions

PROCEDURE

Smear

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

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Elodie Chantalat, MD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04901351 on ClinicalTrials.gov