Completed

NCT Number: NCT05434338

Papillomavirus Post-THErapeutique

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.

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Key information

Conditions

High Grade Intraepithelial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service : Chirurgie et oncologie gynécologique et mammaire, Hôpital Pitié Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPV detection test

Diagnostic Test

Samples taken from the squamocolumnar junction using swabs (UTM Copan)

Other names: PCR HPV test [AnyplexTM HPV28 Detection (Seegene®)] : swab UTM Copan

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

determine if HPV PCR negativity in the immediate postoperative period is associated with persistence of negativity at 6 months.

Time frame: immediate postoperative and at 6 months

compare HPV PCR immediately postopertive and at 6 month
Describe postoperative HPV PCR kinetics according to HPV type.

Time frame: 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
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.

Time frame: immediate postoperative and at 12 months

compare results of HPV PCR performed immediately postoperatively 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.

Time frame: 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.

Time frame: 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
Compare the performance of the results of the PCR HPV Autotests and PCR HPV tests carried out by the practitioner.

Time frame: 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
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).

Time frame: at 12 months

Number of participants with additional cytochemical study ( p16 and Ki67) in case of positive HPV tests with high risk HPV

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PAPOTHE

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jun 28, 2022
Registry last updated: Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.