2024-513081-19-00招募中2 期
HPV2-2303 - Phase 2 clinical trial evaluating secondary HPV vaccination after treatment of high-grade cervical lesions
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- HPV-negative status within 24 months of the initial HPV control test, HPV-negative statu is defined as a negative. If the patient cannot be assessed at 2 years due to the occurrence of cancer beforehand, the observation will be considered a failure (equivalent to the absence of negativation).
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
HPV-negative status within 24 months of the initial HPV control test, HPV-negative statu is defined as a negative. If the patient cannot be assessed at 2 years due to the occurrence of cancer beforehand, the observation will be considered a failure (equivalent to the absence of negativation).
HPV-negative status within 24 months of the initial HPV control test, HPV-negative statu is defined as a negative. If the patient cannot be assessed at 2 years due to the occurrence of cancer beforehand, the observation will be considered a failure (equivalent to the absence of negativation).
次要结局
- 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).
- Adverse Events (AEs) will be assessed according to the NCI-CTCAE V5.0 over the total duration of the vaccination schedule plus 30 days. AEs will be collected after each injection, at the next injection for the first 2 injections, and by a telephone call (+/- consultation if necessary) at 30 days after the 3rd injection. AEs clearly related to the underlying disease or its progression will be excluded. Grade ≥3 AEs will be considered as severe AEs. All serious adverse events will be reported im
- To estimate the incidence of recurrence of high-grade intraepithelial lesion, we will calculate the time between the date of the initial HPV control test and the first of the event (recurrence of high-grade intraepithelial lesion of the uterine cervix, occurrence of HPV-related cancer whatever the location: uterine cervix, vagina, vulva).
- To estimate the incidence of invasive gynaecological cancer (cervix, vagina or vulva), we will calculate the time between the date of the initial HPV control test and the occurrence of HPV-related invasive cancer at any location (cervix, vagina, vulva).
- Compliance with the vaccination schedule will be assessed by o the number of injections received o the timing of injections (time to start vaccination, time between each injections, time between the 1st and 3rd injections).
研究者
Cinical Research Sponsor Unit
Scientific
Centre Oscar Lambret
研究点 (1)
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