Papillomavirus Post-THErapeutique

NCT ID: NCT05434338

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-23
• Study Completion Date: 2024-12-23

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.

Conditions

High Grade Intraepithelial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Major women with HPV-related high-grade intraepithelial lesions

Group Type: OTHER

HPV detection test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

HPV detection test

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffroy Canlorbe, MD, PhD

Role: STUDY_CHAIR

APHP

Locations

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

Paris, , France

Countries

France

Other Identifiers

APHP220619

Identifier Type: -

Identifier Source: org_study_id