Actively Recruiting
Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions
Led by Centre Oscar Lambret · Updated on 2026-03-18
85
Participants Needed
1
Research Sites
363 weeks
Total Duration
On this page
Sponsors
C
Centre Oscar Lambret
Lead Sponsor
C
Canceropôle Nord Ouest
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (6 to 12 months accepted)
- Patients with abnormalities at initial control colposcopy and/or positive biopsy remain eligible
- No contraindication to HPV vaccination with Gardasil 9 (for vaccinated cohort)
- Patient consented to HPV vaccination with Gardasil 9 (for vaccinated cohort)
- Affiliated with a social security system (for vaccinated cohort)
- Informed and signed written consent provided (for vaccinated cohort)
- Patients infected with HIV on antiretroviral therapy are eligible for vaccination
- Patients eligible but refusing vaccination or with contraindications can participate in observational cohort
- No objection to the use of personal data for research purposes (for observational cohort)
You will not qualify if you...
- History of primary HPV vaccination
- History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal)
- Patient refusing HPV vaccination (for vaccinated cohort)
- Patient with contraindication to HPV vaccination with Gardasil 9 (for vaccinated cohort)
- Patient deprived of liberty or under guardianship (for vaccinated cohort)
- Opposition to use of personal data for research purposes (for observational cohort)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
Research Team
E
Emilie HEYMAN-DECOUPIGNY
CONTACT
H
Hugo JOSE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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