Study of the Dynamics of Human Papillomavirus (HPV) Clearance in Post-treatment of High-grade Intraepithelial Lesions (HGIL).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Evaluate the percentage of patients treated surgically for HGILs with a negative HPV PCR sample
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Major women with HPV-related high-grade intraepithelial lesions
Intervention: HPV detection test (Diagnostic Test)
Outcomes
Primary Outcomes
Evaluate the percentage of patients treated surgically for HGILs with a negative HPV PCR sample
Time Frame: immediate postoperative period
The negativity rate will be described using a frequency, with a 95% confidence interval.
Secondary Outcomes
- 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)
- 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)
- 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)
- Describe postoperative HPV PCR kinetics according to HPV type.(at 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)
- 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)
- 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)