Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513081-19-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canceropôle Nord Ouest | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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:
Describing the dynamics of viral clearance in chronic HPV carriers who receive HPV vaccination.
Evaluating the safety of HPV vaccination.
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.
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.
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.
Describing compliance with the proposed vaccination schedule in terms of:
Evaluating the effect of vaccination on:
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccinated patients | Experimental | Human papillomavirus vaccine, nonvalent, Gardasil 9 |
|
| Non-vaccinated patients | No Intervention | no changes to standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Papillomavirus 9-valent Vaccine, Recombinant | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of HPV-negative status | 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). | Within 2 years after the initial HPV control test |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamics of HPV viral clearance | 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) | every 12 months for up to 5 years |
Not provided
Inclusion Criteria:
Common eligibility criteria for the study (for both cohorts) :
Additional eligibility criteria for the clinical trial (Vaccinated patients cohort)
Inclusion criteria for the data study (Non-vaccinated patients cohort)
Patient eligible for the study (a) and not eligible for the clinical trial (b) due to:
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:
Common exclusion criteria for the study (for both cohorts)
Exclusion criteria for the clinical trial (Vaccinated patients cohort)
Exclusion criteria for the data study (Non-vaccinated patients cohort) a) Opposition to the use of their personal data for research purposes
Women with chronic HPV infections, particularly those who have undergone treatment for high-grade cervical lesions.
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie HEYMAN-DECOUPIGNY | Contact | 0320295918 | promotion@o-lambret.fr | |
| Hugo JOSE | Contact | 0320295918 | promotion@o-lambret.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nora ALLOY, MD | Centre Oscar Lambret | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
Not provided
Not provided
Not provided
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..
Not provided
Not provided
Not provided
Not provided
|
| Adverse Events |
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. |
| Throughout the vaccination schedule plus 30 days |
| Incidence of high-grade intraepithelial lesions | 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. | From the initial HPV control test up to the first recurrence event up to 5 years |
| Incidence of invasive gynecological cancer | 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) | From the initial HPV control test to the occurrence of invasive cancer up to 5 years |
| Compliance with vaccination schedule | 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. | Throughout the vaccination period (up to 1 year) |