Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cytologic results of the cervico-uterine smear.
研究概览
简要总结
Lesions classified as "High Grade Squamous Intra-epithelial Lesions" (HSIL) are pre-cervical lesions of the cervix, induced by infection with the Human Papilloma Virus (HPV). The detection and proper management of these lesions greatly reduces the incidence of invasive cervical cancer.
Pap smear remains the most effective tool for early detection of low and high-grade cervical lesions. In Belgium, screening for cervical cancer is recommended every 3 years for women between 25 and 65 years old.
HPV is a virus who possesses certain oncogenic genes who have the ability to inactivate tumor suppressor genes in the host cell. This promotes a tumorigenesis process within the tissues affected by the virus. The majority of human papillomavirus infections are transient and spontaneously cleared by host defense mechanisms, especially in the first two years after exposure. However, 10-20% of infections persist latently and may eventually lead to progression to invasive cervical cancer.
Even high-grade lesions kan naturally be cleared, even more so if the patient is young and immuno-competent. Therefore, the management of HSIL lesions in young women has been modified and consists of adopting mainly a conservative attitude, with controls every 6 months for 2 years. This management makes it possible to avoid unnecessary conizations of the cervix which, in young nulliparous patients, are not devoid of heavy obstetric consequences during subsequent pregnancies (premature birth, perinatal mortality). Cervical conization will only be considered for lesions that progress during follow-up or that persist beyond 2 years. However, this type of follow-up requires that patients be compliant.
Our study has two main objectives:
- to determine the compliance of CHU Brugmann Hospital patients who have been proposed a conservative strategy for the management of HSIL lesions.
- to identify the predictive factors for the persistence and / or progression of high-grade pre-cancerous dysplastic lesions.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients followed within the CHU Brugmann Hospital (no private practices).
- •HSIL lesions confirmed by anatomopathologic analysis on cervical biopsies or cone specimen without evidence of invasive lesions
排除标准
- •Invasive lesions
结局指标
主要结局
Cytologic results of the cervico-uterine smear.
时间窗: Every six months over a period of 24 months
Cytologic results of the cervico-uterine smear. Diagnose established by the anatomo-pathologist.
Patient observance
时间窗: Every six months over a period of 24 months
Numeric value: 1 (optimal), 2 (acceptable), 3 (absent). Groups having benefited from a conservative attitude: Optimal compliance: 4 consultations in 24 months and / or indication of conization. Acceptable compliance: 2 to 3 consultations in 24 months. Observance absent: 0 to 1 consultation in 24 months. Groups having benefited from conization: Optimal compliance: 2 consultations after conisation. Acceptable compliance: 1 after consultation. Observance absent: 0 consultation after conisation.
Endocervix damage
时间窗: Every six months over a period of 24 months
Is the endocervix affected by the HSIL lesion (yes or no) ?
Extent of dysplastic lesions
时间窗: Every six months over a period of 24 months
Defined as the number of quadrants reached by the lesion.
Histologic results of the cervical biopsies
时间窗: Every six months over a period of 24 months
Histologic results of the cervical biopsies.Diagnose established by the anatomo-pathologist.
Immuno-histologic results Ki67
时间窗: Every six months over a period of 24 months
Percentage of Ki67 antibody reactivity on the cervix biopsies
Immuno-histologic results p16
时间窗: Every six months over a period of 24 months
Percentage of p16 antibody reactivity on the cervix biopsies
次要结局
- Gestity(Every six months over a period of 24 months)
- Parity(Every six months over a period of 24 months)
- Quality of colposcopic examinations(Every six months over a period of 24 months)
- Age at first patient visit(1 day)
- Response time to the convocation for colposcopy(Up to 24 months)
- HIV status(Every six months over a period of 24 months)
- Smoking status(Every six months over a period of 24 months)
- HPV status(Every six months over a period of 24 months)
研究者
Catherine Vanpachterbeke
Head of clinic
Brugmann University Hospital