Clinical trial NCT05434338: Papillomavirus Post-THErapeutique
Official title: Study of the Dynamics of Human Papillomavirus (HPV) Clearance in Post-treatment of High-grade Intraepithelial Lesions (HGIL).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Grade Intraepithelial
Keywords: conization
high-grade intraepithelial lesion (HGILs)
post-therapy HPV clearance
HPV test
disappearance kinetics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the percentage of patients treated surgically for HGILs with a negative HPV PCR sample
timeFrame: immediate postoperative period
Secondary outcomes:
measure: determine if HPV PCR negativity in the immediate postoperative period is associated with persistence of negativity at 6 months.
timeFrame: immediate postoperative and at 6 months
measure: Describe postoperative HPV PCR kinetics according to HPV type.
timeFrame: at 1 month, 3 months , 6 months and 12 months
measure: 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.
timeFrame: immediate postoperative and at 12 months
measure: 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.
timeFrame: at 12 months
measure: 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.
timeFrame: immediately after surgery and at 1 month, 3 months , 6 months and 12 months
measure: Compare the performance of the results of the PCR HPV Autotests and PCR HPV tests carried out by the practitioner.
timeFrame: at 1 month, 3 months , 6 months and 12 months
measure: 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).
timeFrame: at 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service : Chirurgie et oncologie gynécologique et mammaire, Hôpital Pitié Salpêtrière
Study officials:
affiliation: APHP
name: Geoffroy Canlorbe, MD, PhD
role: STUDY_CHAIR
References: