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Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of pre-surgical HPV9-valente vaccination in women treated with loop electrosurgical excision (LEEP) for high-grade cervical intraepithelial neoplasia (CIN2+) up to cervical cancer initially invasive (FIGO IA1) - HOPE 9 STUDY
EU CTIS ID: 2024-513704-34-00
What this study is testing
To evaluate the impact of pre-surgical HPV 9-valent vaccination in patients subjected to conization for the management of high-grade cervical intraepithelial neoplasia (CIN2 +) and initially invasive cervical cancer in terms of possible reduction of recurrent post-surgical disease.
- Therapeutic confirmatory (Phase III)
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
- Patients >= 18 years old and ecog performance status <= 1
- Patients diagnosed with high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological findings = CIN2 + and = Ia1 according to the FIGO staging of cervical cancer)
- No fever at the time of vaccination
- No previous HPV vaccination
- Ability to understand and write in Italian
- Signature of informed consent and consent to personal data
You likely can't join if
- Patients enrolled in other clinical trials
- History of allergic reaction or serious adverse events to previous vaccinations
- Assessment of the state of pregnancy at the time of vaccination
- Patients on immunosuppressive therapy
- Subjects who received immunoglobulins or blood products in the 3 months prior to vaccination.
- Thrombocytopenia or any other coagulation disorder that may lead to bleeding following intramuscular administration
See the full eligibility criteria
- Patients >= 18 years old and ecog performance status <= 1
- Patients diagnosed with high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological findings = CIN2 + and = Ia1 according to the FIGO staging of cervical cancer)
- No fever at the time of vaccination
- No previous HPV vaccination
- Ability to understand and write in Italian
- Signature of informed consent and consent to personal data
- Patients enrolled in other clinical trials
- History of allergic reaction or serious adverse events to previous vaccinations
- Assessment of the state of pregnancy at the time of vaccination
- Patients on immunosuppressive therapy
- Subjects who received immunoglobulins or blood products in the 3 months prior to vaccination.
- Thrombocytopenia or any other coagulation disorder that may lead to bleeding following intramuscular administration
- Clinical criteria contraindicating the surgical act of conization
- ECOG performance status =2
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, 65+ 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.