Effective Surveillance and Impact of HPV Vaccination on Screening for Cervical Cancer in Tuscany
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 832
- 试验地点
- 2
- 主要终点
- number of cytological abnormalities in the Experimental arm and in No intervention arm
研究概览
简要总结
The purposes of this study are to evaluate the effectiveness of vaccination in 25-year old women at the time of their first access to cervical cancer screening, to understand the impact of vaccination on screening activity; to evaluate the immune response following vaccination; to study the dynamics of the infection after vaccination, including the possible change in the frequency of non-vaccine HPV types, to evaluate cytological abnormalities reductions in vaccinated women and to assess if HPV test in urine sample could be a useful non-invasive method to monitor HPV status in younger women.
详细描述
The present trial, funded by Istituto Toscano Tumori, started in 2010 and was directed to all women aged 25 (birth cohorts 1985 and 1986), resident in the province of Florence and targeted by the screening program. After receiving approval from the Ethics Committee of the Local Health Unit of Florence, women were invited by invitation letter containing a clear description of the study. All women complying with the invitation were asked to fill in the informed consent document.
Women were randomized 1:2 in the Experimental Arm or in the Control Arm. At enrollment, women in the Experimental Arm, after collection of cervical samples (for Pap-test and HPV test), blood sample (for HPV antibody testing on serum before vaccination) and one first void urine sample (for HPV testing), received free vaccination with Cervarix® (vaccine against HPV 16 and 18, 3 doses scheduled). Women in the Control Arm received usual care, i.e. the collection of cervical sample for Pap test.
All women who signed the informed consent have been enrolled regardless of being sexually active or not. For virgo women cervical sample was not collected.
At the second round of screening (30 months since enrollment), women in both Arms were asked to collect cervical samples (for Pap-test and HPV test) while a new blood sample for HPV antibody testing was collected only in women enrolled in the Experimental Arm.
Women with normal cytology in Control Arm and women with HPV-negative result and normal cytology in Experimental Arm, received a recommendation by mail to repeat screening test after 3 years. Women with abnormal Pap test (Atypical Squamous Cells of Undetermined Significance or more severe, ASC-US+) were referred to immediate colposcopy at the Cancer Prevention and Research Insitute. Women with normal cytology and HPV positive were called after one year to repeat HPV test and Pap test. If HPV and Pap test were negative, women repeated both test after 30 months from enrolment. Otherwise if HPV test remained positive and/or cytology abnormalities were detected women were referred for colposcopy: if colposcopy didn't reveal high grade lesions (≤ CIN2) women repeated HPV and Pap test after 30 months from enrollment, if colposcopy revealed final histological diagnosis of CIN2+ lesions, women were recommended for an excisional treatment (both for study and control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •resident in Florence
- •invited for the first time to the cervical cancer screening in Florence
- •aged 25 years
排除标准
- 未提供
研究组 & 干预措施
no HPV vaccine
No delivery of HPV vaccine
HPV vaccine (Cervarix®, GlaxoSmithKline)
Delivery of HPV vaccine (Cervarix®, GlaxoSmithKline) at 0, 1, 6 months
干预措施: Cervarix®, GlaxoSmithKline (Biological)
结局指标
主要结局
number of cytological abnormalities in the Experimental arm and in No intervention arm
时间窗: 30 months
number of HR-HPV infections and number of infections due to HPV vaccine types in cervical sample in the Experimental arm and in No intervention arm
时间窗: 30 months
次要结局
- Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers before vaccination(at enrollment)
- Number of subjects seropositive for HPV 16, 18, 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 at enrollment(enrollment)
- Number of participants reporting Adverse Events(within 14 days following any injection)
- HPV identification in urine samples(at enrollment)
- Number of subjects seropositive for HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 after vaccination(30 months)
- Anti-HPV16,18 31, 33, 35, 39, 45, 52, 56, 58, 59, 68 Antibody Titers after vaccination(30 months)
研究者
Francesca Carozzi
Biologist Director
Cancer Prevention and Research Institute, Italy