Retrospective Cohort Study to Analyze Whether Prophylactic Vaccination Against HPV Can Reduce the Risk of Recurrence in Women Who Have Received an Excisional Therapy for HSIL / CIN2-3. Recurrence is Defined as the Detection of Infection by the Same HPV Genotype for at Least 6-12 Months (Persistent Infection), and / or Cytological Alteration and / or Cervical and / or Vaginal Histological Lesion of Any Grade (SIL / CIN / VaIN) in Patients With Negative Cotest in the First Post Control.
试验速览
- 阶段
- 不适用
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-related disease will be evaluated. For this purpose, the percentage of cervical lesion recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015.
It will be an essential requirement that the patient provide a vaccination card from their health center where there is proof of their immunization status and date of administration.
Inclusion criteria:
- Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
- Women who sign informed consent.
- Patients with negative results in the first post-surgery control.
- Patients who have received HPV vaccination and provide vaccination card.
Exclusion criteria:
- Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study.
- Patients treated by an indication other than HSIL/CIN.
- Patients under immunosuppression conditions.
详细描述
A retrospective cohort study of women treated by excisional therapy due to HSIL/ CIN at Clínico San Carlos Hospital (Madrid) between 2012-2018. The effectiveness of prophylactic vaccination against HPV in women treated for HPV-linked disease will be evaluated. For this purpose, the percentage of lesional recurrence among a group of treated and vaccinated women against HPV between the years 2015-2018 will be compared with a control group of treated and non-vaccinated women against HPV since 2012-2015. The data will be obtained through the review of clinical records.
Our protocol is explained above:
HPV detection method:
The detection of HPV is performed on a liquid basis by means of the CLARK PAPILOMAVIRUS HUMAN test that detects the presence of the HPV virus (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71.72, 73, 81, 82, 83, 84, 85 and 89). The test has a diagnostic sensitivity of 98.2% and a diagnostic specificity of 100% and analytical specificity: 100%. The analytical sensitivity of this test is 100% when the number of copies is 1,000 or 10,000 depending on the type of HPV. The Laboratory has carried out external quality control of the SEAP.
Pre-surgical evaluation:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
- •Women who sign informed consent.
- •Patients with negative results in the first post-surgery control.
- •Patients who have received HPV vaccination and provide vaccination card.
排除标准
- •Women who do not wish or cannot give their informed consent and / or do not comply with the requirements of the study.
- •Patients treated by an indication other than HSIL/CIN.
- •Patients under immunosuppression conditions.
研究组 & 干预措施
vaccinated women
- Women older than 18 years who received excisional therapy due to HSIL /CIN injury confirmed histologically.
- Women who sign informed consent.
- Patients with negative results in the first post-surgery control.
- Patients who have received HPV vaccination and provide vaccination card.
干预措施: HPV vaccine (Drug)
结局指标
主要结局
Recurrence
时间窗: 2 years
defined as the existence of persistent HPV infection and / or presence of cytological abnormality and / or presence of SIL / CIN / VaIN of any grade.
次要结局
- Age, type of virus, degree of injury, variables related to demographic and histological data of the patient, date of 1st dose of vaccine.(2 years)
研究者
ANDREA CASAJUANA
PLUVIO CORONADO MARTÍN
Hospital San Carlos, Madrid