BridgeMD
HPV2-2303 - Phase 2 clinical trial evaluating secondary HPV vaccination after treatment of high-grade cervical lesions
EU CTIS ID: 2024-513081-19-00
What this study is testing
To estimate the proportion of HPV-negative status within two years of the initial positive HPV control test, in women over 45 years old who are chronic HPV carriers, after treatment for high-grade cervical intraepithelial lesion and HPV vaccination.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged over 45
- Patient treated by conisation for a high-grade cervical lesion
- Positive HPV test at the recommended 6-month post-operative follow-up (a delay of 6 to 12 months will be accepted) leading to an indication for a follow-up colposcopy (+/- biopsy) in accordance with standard surveillance practices.
- For cohort "vaccinated patients" : No contraindication to HPV vaccination with Gardasil 9
- For cohort "vaccinated patients" : Patient who has consented to HPV vaccination with Gardasil 9
- For cohort "vaccinated patients": Affiliated to a public health insurance program
You likely can't join if
- History of primary vaccination
- History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal)
- For cohort “vaccinated patients” : Patient refusing vaccination
- For cohort " vaccinated patients" : Patient with a contraindication to HPV vaccination with Gardasil 9
- For cohort "vaccinated patients" : Patient deprived of liberty or under guardianship
- For cohort “non-vaccinated patients”: Objection to the use of their personal data for research purposes
See the full eligibility criteria
- Patient aged over 45
- Patient treated by conisation for a high-grade cervical lesion
- Positive HPV test at the recommended 6-month post-operative follow-up (a delay of 6 to 12 months will be accepted) leading to an indication for a follow-up colposcopy (+/- biopsy) in accordance with standard surveillance practices.
- For cohort "vaccinated patients" : No contraindication to HPV vaccination with Gardasil 9
- For cohort "vaccinated patients" : Patient who has consented to HPV vaccination with Gardasil 9
- For cohort "vaccinated patients": Affiliated to a public health insurance program
- For cohort "vaccinated patients" : Signed, informed consent form
- For cohort "non-vaccinated patients" : Refusal of vaccination or contraindication to vaccination
- For cohort "non vaccinated patients" : Non-objection to the use of their personal data for research purposes
- History of primary vaccination
- History of HPV-induced invasive cancer (cervical, vaginal, vulvar, anal, oropharyngeal)
- For cohort “vaccinated patients” : Patient refusing vaccination
- For cohort " vaccinated patients" : Patient with a contraindication to HPV vaccination with Gardasil 9
- For cohort "vaccinated patients" : Patient deprived of liberty or under guardianship
- For cohort “non-vaccinated patients”: Objection to the use of their personal data for research purposes
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.