Cervical Lesion
Conditions
Keywords
HPV, oncology, secondary prevention, cervix, vaccination
Brief summary
This is a single-center, Phase II interventional study evaluating secondary HPV vaccination after treatment of high-grade cervical lesions. The study aims to estimate the rate of HPV clearance within two years following an initial positive HPV control test in women over 45 years of age who are chronic HPV carriers and have undergone treatment for high-grade intraepithelial cervical lesions, and who receive HPV vaccination. The study includes two cohorts: 1. Eligible patients who consent to vaccination will participate in a prospective, single-center, single-arm, interventional clinical trial (Category 2). 2. Non-vaccinated patients will be included in a non-interventional observational study, with no changes to their standard care.
Detailed description
The aim of this study is to estimate the proportion of HPV clearance within two years following an initial positive HPV control test in women over 45 years old who are chronic HPV carriers and have undergone treatment for high-grade intraepithelial cervical lesions. These women will receive HPV vaccination as part of the study. Other objectives of the study include: 1. Describing the dynamics of viral clearance in chronic HPV carriers who receive HPV vaccination. 2. Evaluating the safety of HPV vaccination. 3. Estimating the incidence of recurrence of high-grade intraepithelial cervical lesions in chronic HPV carriers after surgical treatment of the initial lesion and HPV vaccination. 4. Estimating the incidence of invasive gynecological cancers (cervical, vaginal, or vulvar) in chronic HPV carriers after surgical treatment of the initial lesion and HPV vaccination. 5. Identifying factors associated with the refusal of HPV vaccination, such as smoking, parity, body mass index, employment status, education level, family history, and marital status. 6. Describing compliance with the proposed vaccination schedule in terms of: 1. Number of injections completed. 2. Adherence to the timing of injections. 7. Evaluating the effect of vaccination on: 1. HPV clearance within two years. 2. The dynamics of viral clearance. 3. The risk of recurrence of high-grade intraepithelial lesions. 4. The risk of developing invasive gynecological cancers (cervical, vaginal, or vulvar). by comparing vaccinated patients included in the clinical trial with the cohort of non-vaccinated patients (those who refused HPV vaccination or for other reasons).
Interventions
HPV vaccine administered in three doses: first dose on day 1, second dose 2 months later, and third dose 4 months after the second dose, within a one-year period.
Sponsors
Centre Oscar Lambret
Canceropôle Nord Ouest
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study uses a non-randomized design with two cohorts: vaccinated patients in a single-arm clinical trial and non-vaccinated patients in an observational study, chosen to reflect real-life scenarios and ensure comprehensive data collection despite the absence of randomization..
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Common eligibility criteria for the study (for both cohorts) : 1. Female patient over 45 years old 2. Patient treated by conization for high-grade cervical epithelial lesion 3. Positive HPV test at the 6-month post-operative control (a delay of 6 to 12 months will be accepted), leading to an indication for a control colposcopy (+/- biopsy) according to standard surveillance practices. 4. N.B. : Patients with abnormalities at the initial control colposcopy and/or positive biopsy remain eligible for the study, whether vaccinated or not. 2. Additional eligibility criteria for the clinical trial (Vaccinated patients cohort) 1. No contraindication to HPV vaccination with Gardasil 9 2. Patient consented to HPV vaccination with Gardasil 9 3. Affiliated with a social security system 4. Informed and signed written consent provided 5. N.B. : Patients infected with HIV are eligible for the vaccine trial provided they are on antiretroviral therapy. 3. Inclusion criteria for the data study (Non-vaccinated patients cohort) 1. Patient eligible for the study (a) and not eligible for the clinical trial (b) due to: * refusal of vaccination, or * A contraindication to vaccination 2. No objection to the use of their personal data for research purposes N.B. : A patient who initially refused vaccination may later request to be vaccinated as part of the trial after signing the consent form. The vaccine trial analysis will include all patients who started vaccination within 6 months after the initial HPV control test.
Exclusion criteria
1. Common
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of HPV-negative status | Within 2 years after the initial HPV control test | The primary outcome is to estimate the proportion of HPV-negativation status within two years of the initial positive HPV control test. Negativation is defined as a negative HPV test result. If the patient cannot be evaluated due to the occurrence of cancer, this will be considered a failure (equivalent to absence of negativation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamics of HPV viral clearance | every 12 months for up to 5 years | HPV status over time assessed by smear every 12 months until HPV-negative status (in the study: within 5 years of follow-up). When the test is negative, a follow-up smear is performed three years later (in the study: within 5 years of follow-up) |
| Adverse Events | Throughout the vaccination schedule plus 30 days | Adverse events will be recorded and evaluated according to the NCI-CTCAE V5.0 scale. AEs will be documented after each vaccination, during subsequent injections, and through a follow-up phone call 30 days after the third injection. Severe Adverse Events (grade ≥3) will be considered significant. |
| Incidence of high-grade intraepithelial lesions | From the initial HPV control test up to the first recurrence event up to 5 years | The time to recurrence of high-grade cervical lesions will be calculated from the date of the initial HPV control test to the first documented event of lesion recurrence, as indicated by clinical follow-up and diagnostic testing. |
| Incidence of invasive gynecological cancer | From the initial HPV control test to the occurrence of invasive cancer up to 5 years | The incidence of invasive gynecological cancers (cervix, vagina, vulva) will be determined by calculating the time from the initial HPV control test to the first occurrence of HPV-related invasive cancer at any sites (cervix, vagina, vulva) |
| Compliance with vaccination schedule | Throughout the vaccination period (up to 1 year) | Compliance will be measured by the number of vaccine doses received and adherence to the recommended timing between injections, including the interval between the 1st and 3rd doses of Gardasil 9. |
Countries
France
Contacts
CONTACTEmilie HEYMAN-DECOUPIGNY
CONTACTHugo JOSE
STUDY_DIRECTORNora ALLOY, MD
Centre Oscar Lambret
Outcome results
None listed