Papillomavirus Post-THErapeutique (PAPOTHE)

June 18, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75013
        • Service : Chirurgie et oncologie gynécologique et mammaire, Hôpital Pitié Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Major women with HPV-related high-grade intraepithelial lesions
Diagnostic test: HPV detection test
Samples taken from the squamocolumnar junction using swabs (UTM Copan)
Other Names:
  • PCR HPV test [AnyplexTM HPV28 Detection (Seegene®)] : swab UTM Copan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
immediate postoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
immediate postoperative and at 6 months
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
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.
Time Frame: immediate postoperative and at 12 months
compare results of HPV PCR performed immediately postoperatively and at 12 months
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.
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
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.
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
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.
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
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).
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
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Geoffroy Canlorbe, MD, PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP220619

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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