An interventional study of HPV detection test in High Grade Intraepithelial, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
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 :
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Diagnostic Test: HPV detection test
Samples taken from the squamocolumnar junction using swabs (UTM Copan)
Also known as: PCR HPV test [AnyplexTM HPV28 Detection (Seegene®)] : swab UTM Copan
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.
Time frame: immediate postoperative period
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 12 months
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris