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New treatment option for Cervical Lesion
Official title Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions
ClinicalTrials.gov ID: NCT06658405
What this study is testing
What is Human Papillomavirus 9-valent Vaccine, Recombinant?
Human Papillomavirus 9-valent Vaccine, Recombinant is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for cervical lesion.
Also referred to as Gardasil 9.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, women only
You may be able to join if
- Common eligibility criteria for the study (for both cohorts) :
- Female patient over 45 years old
- Patient treated by conization for high-grade cervical epithelial lesion
- 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...
- N.B. : Patients with abnormalities at the initial control colposcopy and/or positive biopsy remain eligible for the study, whether vaccinated or not.
You likely can't join if
- Common exclusion criteria for the study (for both cohorts)
- History of primary HPV vaccination
- History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal cancer)
- Exclusion criteria for the clinical trial (Vaccinated patients cohort)
- Patient refusing HPV vaccination
- Patient with a contraindication to HPV vaccination with Gardasil 9
See the full eligibility criteria
- Common eligibility criteria for the study (for both cohorts) :
- Female patient over 45 years old
- Patient treated by conization for high-grade cervical epithelial lesion
- 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.
- N.B. : Patients with abnormalities at the initial control colposcopy and/or positive biopsy remain eligible for the study, whether vaccinated or not.
- Additional eligibility criteria for the clinical trial (Vaccinated patients cohort)
- No contraindication to HPV vaccination with Gardasil 9
- Patient consented to HPV vaccination with Gardasil 9
- Affiliated with a social security system
- Informed and signed written consent provided
- N.B. : Patients infected with HIV are eligible for the vaccine trial provided they are on antiretroviral therapy.
- for the data study (Non-vaccinated patients cohort)
- Patient eligible for the study (a) and not eligible for the clinical trial (b) due to:
- refusal of vaccination, or
- A contraindication to vaccination
- 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...
- Common exclusion criteria for the study (for both cohorts)
- History of primary HPV vaccination
- History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal cancer)
- Exclusion criteria for the clinical trial (Vaccinated patients cohort)
- Patient refusing HPV vaccination
- Patient with a contraindication to HPV vaccination with Gardasil 9
- Patient deprived of liberty or under guardianship
- Exclusion criteria for the data study (Non-vaccinated patients cohort) a) Opposition to the use of their personal data for research purposes
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.