Gestione Conservativa di Lesioni CIN2 e Valutazione di Biomarcatori Indicativi di Regressione
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 4
- 主要终点
- CIN2 clinical outcome by DNA methylation
研究概览
简要总结
Prospective study including women aged 25-45 years, adherent to the cervical screening program of four different centers of the Veneto region, with a diagnosis of CIN2 lesion. After enrollment according to predefined criteria, and informed consent to participate, the CIN2 lesions are managed by follow-up; cases with progressive lesions will be treated immediately, cases with CIN2 persistence for more than 12 months will be treated as well. Viral, molecular and immunocytochemical biomarkers will be studied, and evaluated in relation to the clinical outcome.
详细描述
Women aged 25-45 years, adherent to the organized population-based cervical screening program, with a histological diagnosis of CIN2 and fulfilling the inclusion criteria will be invited to participate to the study, previously providing specific information; in case of acceptance, informed consent is signed.
STUDY PROTOCOL:
The adherent women will attend periodical control visits:
- every 6 months up to 24 months, with performance of: pap test (PT) and colposcopy (with biopsy in case of visible alterations);
- at 6 and 12 months control visit: a liquid-based sample of cervical cells will be collected for the biomarkers' analyses.
BIOMARKERS:
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
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age range 25-45 years,
- •CIN2 lesions located in the exocervix and completely visible at colposcopy.
排除标准
- •age >45 years;
- •history of previous high-grade lesions;
- •squamo-columnar junction not completely visible (type 3);
- •cytology with suspect or indicative for invasive lesion;
- •lesions exclusively located in the endocervix;
- •lesions located in the exocervix but not completely visible;
- •pregnancy
结局指标
主要结局
CIN2 clinical outcome by DNA methylation
时间窗: Through study completion, an average of 2 years.
Rate of CIN2 regression will be calculated in relation to DNA methylation of cellular and viral genes (number of regressed hypermethylated CIN2 lesions / total number of CIN2 lesions with valid result for each gene analyzed).
CIN2 clinical outcome by HPV genotype
时间窗: Through study completion, an average of 2 years.
Rate of CIN2 regression will be calculated in relation to positivity for HPV16 vs positivity for other high-risk types (number of regressed HPV16-related CIN2 lesions / total number of HPV16-related CIN2 vs number of regressed non-HPV16-related CIN2 lesions / total number of non-HPV16-related CIN2 lesions).
Rate of spontaneous regression of CIN2 lesions
时间窗: Through study completion, an average of 2 years.
Eligible women will not be treated at diagnosis, but periodically followed-up. Treatment will be provided for progressive lesions and lesions persisting more than 12 months. The rates of lesion regression will be calculated: number of lesions regressed to CIN1 or normal / total number of cases.
CIN2 clinical outcome by p16/ki67 protein expression
时间窗: Through study completion, an average of 2 years.
Rate of CIN2 regression will be calculated in relation to positivity for p16/ki67 expression (number of regressed p16/ki67-positive CIN2 lesions / total number of CIN2 lesions with valid result for p16/ki67 expression).
次要结局
- Adhesion to CIN2 conservative management.(2 years)
研究者
Annarosa Del Mistro
Head of HPV laboratory
Istituto Oncologico Veneto IRCCS