High Grade IntraepithelialPAPOTHENCT05434338
Papillomavirus Post-THErapeutique
A study testing HPV detection test in people with High Grade Intraepithelial, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Grade Intraepithelial
- What is being tested?
- HPV detection test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2022to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Service : Chirurgie et oncologie gynécologique et mammaire, Hôpital Pitié Salpêtrière
Paris, 75013
About this study
Official title: 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.
Read the 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
- Being tested
- HPV detection test
- Keywords
- conization, high-grade intraepithelial lesion (HGILs), post-therapy HPV clearance, HPV test, disappearance kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV detection testDiagnostic test
Also called PCR HPV test [AnyplexTM HPV28 Detection (Seegene®)] : swab UTM Copan
Samples taken from the squamocolumnar junction using swabs (UTM Copan)
| Study group | Role | What they receive |
|---|---|---|
| Major women with HPV-related high-grade intraepithelial lesions | Other | Not described Receives: Diagnostic Test: HPV detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate postoperative period
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start23 Dec 2022
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade IntraepithelialStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffroy Canlorbe, MD, PhD, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434338
- Sponsor's protocol ID
- APHP220619
- Acronym
- PAPOTHE
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Dynamics of Human Papillomavirus (HPV) Clearance in Post-treatment of High-grade Intraepithelial Lesions (HGIL).
- ClinicalTrials.gov ID
- NCT05434338
- Acronym / sponsor ID
- PAPOTHE / APHP220619
- Conditions
- High Grade Intraepithelial
- Keywords
- conization, high-grade intraepithelial lesion (HGILs), post-therapy HPV clearance, HPV test, disappearance kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major women with HPV-related high-grade intraepithelial lesions | Other | Diagnostic Test: HPV detection test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Immunocompromised patients (HIV infection, or iatrogenic)
- Patient with a history of treated HGIL
- Patient who does not understand French
- Patient unable to express consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV detection testAlso: PCR HPV test [AnyplexTM HPV28 Detection (Seegene®)] : swab UTM CopanSamples taken from the squamocolumnar junction using swabs (UTM Copan) | Diagnostic test | Major women with HPV-related high-grade intraepithelial lesions |
Primary outcome
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.
7 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
Describe postoperative HPV PCR kinetics according to HPV type.
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.
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.
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.
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.
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).
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffroy Canlorbe, MD, PhD study chair
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV detection test in people with High Grade Intraepithelial, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the percentage of patients treated surgically for HGILs with a negative HPV PCR sample (time frame: immediate postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.