Predictive Value of p16 and Ki-67 Immunohistochemical Staining and NK Cells in Expectant Management of Cervical Intraepithelial Neoplasia Grade 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Status of cervix pathology using cervical smear test (CIN grade)
研究概览
简要总结
The objective of this study is to evaluate the outcome of cervical intraepithelial neoplasia grade 2 (CIN-II) patients followed up without treatment for 24 months according to p16 and ki-67 immunohistochemical staining and to the expression of NK cell receptors.
详细描述
Cervical cancer and its precursor lesions, cervical intraepithelial neoplasia (CIN), represents a significant public health problem,induced by persistent infection of human papillomavirus (HPV). It is known that a significant percentage of CIN regresses spontaneously and only a minority of these lesions progress to cervical cancer. CIN-II is an intermediate state that can regress to CIN-I or less, or progress to CIN-III spontaneously. The rate of spontaneous regression and progression in follow-up studies are around 40-60% and 10-20%, respectively. Overestimating CIN-II lesions may cause overtreatment by excisional treatment and increase the risk of subsequent obstetric complications.
Patients newly diagnosed with CIN-II colposcopy-directed biopsy who agreed to follow up at four months intervals for at least 12 months with cervical cytology and colposcopy, were prospectively recruited. p16, ki-67 and NK receptors expression were analyzed in all CIN-II biopsies. Total regression, partial regression, persistence and progression rates of CIN-II were defined as a final outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •preferred expectant management than immediate treatment
- •exocervical histological diagnosis of CIN-II
- •lesion completely visualized by colposcopy
- •entire squamocolumnar junction of the cervix was visible
- •showing no evidence of any immunodeficiency disease
- •no history of previous cervical treatment
- •could be followed-up every four months during one year
- •signed consent form
排除标准
- •not coming to follow up appointments
结局指标
主要结局
Status of cervix pathology using cervical smear test (CIN grade)
时间窗: 2 years
Cervical cytology test and colposcopy every 4 months starting with diagnose CIN-II or CIN-III means presence of lesion, CIN-I is regression of the lesion, and Negative is abscence of lesion.
次要结局
未报告次要终点
研究者
Jordi Genoves
MD, PhD
Parc de Salut Mar