Papillomavirus Post-THErapeutique

Study Overview
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Brief Summary
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In recent years, studies have multiplied to demonstrate the value of performing an HPV test compared to a cervical smear test (CSP) in cervical cancer screening but also in the follow-up of surgical removal of high-grade intraepithelial lesions (HGILs). Thus, since June 2019, the High Health Authority recommends performing HPV genome testing by PCR for primary cervical cancer screening. Since September 2019, the National Cancer Institute recommends an HPV test in the follow-up of HGILs 6 months after conization. However, this delay was determined thanks to the previous recommendations which advocated a cervical smear test 6 months after conization. Thus, the kinetics of HPV clearance in the immediate postoperative period and in the 6 months following surgical excision remain unknown to this day. A better knowledge of the clearance of HPV postoperatively would allow to adapt and simplify the follow-up of the patients and to personalize it according to the type of HPV.

Detailed Description
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For research purposes, on the day of surgery, specimens at the squamocolumnar junction intraoperatively before and after surgical removal of the HGILs will be taken. Then at follow-up visits at M1 (care, +/-3 weeks), M3 (research, +/- 6 weeks), M6 (care, +/- 6 weeks), and M12 (care, +/- 6 weeks), two types of sampling will be performed : A self-sampling, performed by the patient at the vaginal level during the follow-up consultations (before the gynecological examination) After the speculum has been inserted, a swab sample will be taken by the doctor at the squamocolumnar junction. This procedure will be carried out before any other procedures expected as part of the treatment [colposcopy +/- biopsy(s)], All of these samples for HPV testing will be sent to the virology laboratory of the Pitié Salpêtrière Hospital, where they will be stored and analyzed.

Official Title
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Study of the Dynamics of Human Papillomavirus (HPV) Clearance in Post-treatment of High-grade Intraepithelial Lesions (HGIL).

Conditions
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High Grade Intraepithelial

Intervention / Treatment
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* Diagnostic Test: HPV detection test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women Over 18 years old High-grade intraepithelial lesion (WHO classification) Intracervical neoplasms 2 and 3, Richart classification Collection of written, free and informed consent Affiliation to a social security scheme Exclusion Criteria: Immunocompromised patients (HIV infection, or iatrogenic) Patient with a history of treated HGIL Patient who does not understand French Patient unable to express consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Major women with HPV-related high-grade intraepithelial lesions<br> | Diagnostic Test: HPV detection test<br>* Samples taken from the squamocolumnar junction using swabs (UTM Copan)<br>* Other names: PCR HPV test [AnyplexTM HPV28 Detection (Seegene®)] : swab UTM Copan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the percentage of patients treated surgically for HGILs with a negative HPV PCR sample | The negativity rate will be described using a frequency, with a 95% confidence interval. | immediate postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine if HPV PCR negativity in the immediate postoperative period is associated with persistence of negativity at 6 months. | compare HPV PCR immediately postopertive and at 6 month | immediate postoperative and at 6 months | 
| Describe postoperative HPV PCR kinetics according to HPV type. | Compare type of HPV determined on postoperative HPV PCRat 1 month, 3 months , 6 months and 12 months | at 1 month, 3 months , 6 months and 12 months | 
| Evaluate the association between the result of the HPV PCR in the immediate postoperative period and the rate of risk of relapse/persistence of LIEHGs in the year following the treatment. | compare results of HPV PCR performed immediately postoperatively and at 12 months | immediate postoperative and at 12 months | 
| Assess the association between the date of positivity of the HPV PCR and a risk of recurrence/persistence of high-grade dysplasia over the one-year follow-up period. | calculation of the time between HPV PCR positivity at follow-up and development/persistence of high-grade dysplasia on biopsy over the one-year follow-up period | at 12 months | 
| Evaluate the evolution of the negativity of the HPV tests at 0, 1, 3, 6 and 12 months in order to define an optimized follow-up. | comparison of the negativity of the HPV PCR performed immediately after surgery, at 1 month, 3 months , 6 months and 12 months | immediately after surgery and at 1 month, 3 months , 6 months and 12 months | 
| Compare the performance of the results of the PCR HPV Autotests and PCR HPV tests carried out by the practitioner. | comparison of patient self-test results at 1 month, 3 months , 6 months and 12 months prior to the consultation | at 1 month, 3 months , 6 months and 12 months | 
| Determination of the real risk of lesion persistence and consider de-escalation monitoring via the sorting of positive HPV-HR by a cytochemical study (p16 and Ki67). | Number of participants with additional cytochemical study ( p16 and Ki67) in case of positive HPV tests with high risk HPV | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conization, high-grade intraepithelial lesion (HGILs), post-therapy HPV clearance, HPV test, disappearance kinetics