Involvement of Matrix Metalloproteinases and Association With the Expression of Human Papillomavirus in Dysplasias and Cancers of the Cervix
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
研究概览
简要总结
This study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.
详细描述
Cervical cancer is the second most common cancer among European women under 45 years old. It is secondary to cervical dysplasia induced by persistent human papillomavirus infection. The involvement of matrix metalloproteinases in carcinogenesis of the cervix is real, but their expressions vary according to the published series. An association between the expression of MMPs and that of the human papillomavirus deserves to be explored, as this can have a prognostic influence in the case of gradual expression demonstrated in the development of (pre) cancerous lesions of the cervix.
This study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For control group:
- •Age between 20 and 65 years
- •Patients hospitalized for partial or total removal of the cervix
- •Absence of cervical lesion observed on biopsy or hysterectomy
- •Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study)
- •Affiliate or beneficiary of a social security scheme
- •For dysplasia and cancer group:
- •Age between 20 and 65 years
- •Cervical Intraepithelial Neoplasia or previously untreated cervical cancer
- •Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study)
- •Affiliate or beneficiary of a social security scheme
排除标准
- •For control group:
- •History of laser or conisation
- •Known antecedent of HIV infection
- •Congenital or acquired immunodepression
- •Long-term treatment with corticosteroids or immunosuppressants
- •Persons placed under the protection of justice
- •For dysplasia and cancer group:
- •History of laser or conisation
- •Pre-treatment of invasive cancers by radiotherapy or chemotherapy
- •Known antecedent of HIV infection
- •Congenital or acquired immunodepression
- •Long-term treatment with corticosteroids or immunosuppressants
- •Persons placed under the protection of justice
研究组 & 干预措施
Control group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
干预措施: Vaginal samples (biopsies + vaginal smear) (Other)
Low grade lesion group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
干预措施: Vaginal samples (biopsies + vaginal smear) (Other)
High grade lesions group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
干预措施: Vaginal samples (biopsies + vaginal smear) (Other)
Cancer group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
干预措施: Vaginal samples (biopsies + vaginal smear) (Other)
结局指标
主要结局
Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
时间窗: At the screening
The immunohistochemical score is the modified HScore, also called Quickscore. It is calculated by multiplying the percentage of cells that are marked (from 0 to 100) by intensity (from 0 to 3). The total score is between 0 and 300. This score will be defined on normal, tumoral and stromal cells according to the analyzed tissue (normal, dysplasias or cancer)
Immunohistochemical score of expressions of matrix metalloproteinases
时间窗: At the screening
The immunohistochemical score is the modified HScore, also called Quickscore. It is calculated by multiplying the percentage of cells that are marked (from 0 to 100) by intensity (from 0 to 3). The total score is between 0 and 300. This score will be defined on normal, tumoral and stromal cells according to the analyzed tissue (normal, dysplasias or cancer)
次要结局
未报告次要终点