Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- at least one anal cancer
研究概览
简要总结
Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.
详细描述
"Background : Incidence of anal carcinoma (AC) is considerably increasing, but no data on risk of AC in patient with anal AIN3 lesions are available, nor french recommendations about screening and treatment of anal AIN3 lesions.
Objective : Evaluation of the AC incidence in patient with anal AIN3 lesions, and factors associated with this AC.
Population : Patients with a diagnosis of anal AIN3 lesion will be included and followed for 3 years. Patients with past history of AC won't be included.
Study design : Retrospective cohort study will be conducted from 2000 using diagnostic codes of anal AIN3 lesion in histo-pathology departments. Then a prospective cohort study will be conducted with new diagnoses of anal AIN3 lesion.
Outcome : The main outcome is histology proven AC. AC identification can be done either by using diagnostic codes of AC in histo-pathology departments (for retrospective cases), or prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the cohort, patients have to:
- •have an anal AIN3 (including Bowen's disease) diagnosed by histology (screening population, post-operative discovery...)
- •Aposteriori for patients with a history of anal AIN3 complicated or not by an anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since January 1st
- •At the diagnostic for the new anal AIN3 Units care involved in the study are those involved in the follow-up of patients with anal pathologies en France, especially anal cancer. Samples are analyzed by the laboratories of anatomopathology of the hospitals where the patients are diagnosed. These points make the histological data bases reliable and allow clearly identifying cases of anal ain3 retrospectively since
- •Taking in account the number and quality of the units care involved in the study and the way cases are identified, we think our recruitment will be exhaustive in France, to limit selection bias.
- •Patient's non opposition to study
排除标准
- •history of anal carcinoma without any history of anal AIN3 lesion
- •impossible follow-up for the duration of the study (3 years or more)
- •patient aged under 18
结局指标
主要结局
at least one anal cancer
时间窗: 3-year incidence of anal carcinoma
the first diagnosis of anal carcinoma
次要结局
- Observance(3 years)
- patient's feelings about his therapeutic care and impact on his emotional life(3 years)