Papillomavirus Post-THErapeutique

Not Applicable

Recruiting

• Conditions: High Grade Intraepithelial
• Interventions: Diagnostic Test: HPV detection test

• Registration Number: NCT05434338
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-27
• Study First Posted: 2022-06-28
• Status Verified: 2022-10
• Study Start: 2022-12-23
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-03
• Primary Completion: 2023-12-23
• Study Completion: 2024-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Major women with HPV-related high-grade intraepithelial lesions	HPV detection test	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compare the performance of the results of the PCR HPV Autotests and PCR HPV tests carried out by the practitioner.	at 1 month, 3 months , 6 months and 12 months	comparison of patient self-test results at 1 month, 3 months , 6 months and 12 months prior to the consultation
Describe postoperative HPV PCR kinetics according to HPV type.	at 1 month, 3 months , 6 months and 12 months	Compare type of HPV determined on postoperative HPV PCRat 1 month, 3 months , 6 months and 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.	at 12 months	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
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.	immediately after surgery and at 1 month, 3 months , 6 months and 12 months	comparison of the negativity of the HPV PCR performed immediately after surgery, at 1 month, 3 months , 6 months and 12 months
determine if HPV PCR negativity in the immediate postoperative period is associated with persistence of negativity at 6 months.	immediate postoperative and at 6 months	compare HPV PCR immediately postopertive and at 6 month
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.	immediate postoperative and at 12 months	compare results of HPV PCR performed immediately postoperatively and at 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).	at 12 months	Number of participants with additional cytochemical study ( p16 and Ki67) in case of positive HPV tests with high risk HPV

Trial Locations

Locations (1)

Service : Chirurgie et oncologie gynécologique et mammaire, Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France