Papillomavirus Post-THErapeutique (PAPOTHE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: High Grade Intraepithelial

Treatments: Diagnostic Test: HPV detection test

Study type: Interventional

Funder types: Other

Identifiers

NCT05434338

APHP220619

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Major women with HPV-related high-grade intraepithelial lesions

Other group

Treatment:

Diagnostic Test: HPV detection test