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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients who have given their written consent to participate in the study.

Person affiliated or beneficiary of a social security scheme.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Smear

    Procedure/Surgery

    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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients chronically infected with HPVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acceptance by the patient (yes / no binary variable) of ENT and / or anal samples in addition to the cervical sample during an annual gynecological follow-up.

Time frame
Inclusion day (day 0)
2

Number of sites sampled

It will be collected anonymously if spontaneously explained by the patient.

Time frame
Inclusion day (day 0)
3

Reasons for refusing multi-site samples

Time frame
Inclusion day (day 0)

Secondary outcomes

1

Positivity to HPV tests for at least one of the other sites (ENT or anal)

Time frame
Inclusion day (day 0)
2

Identification of HPV + subtypes on the different sites

Time frame
Inclusion day (day 0)

Other outcomes

Sponsors and contacts

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