Incidence, Risk Factor, Treatment and Overall Survival of Locally Recurrent Rectal Cancer: a Retrospective, Population-based Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,431
- 主要终点
- Risk factors for development of locally recurrent rectal cancer in curatively treated primary rectal cancer patients
研究概览
简要总结
Data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the Netherlands over the first six months of 2015. Three-year cumulative incidence, risk factors, treatment and three-year OS of locally recurrent rectal cancer were determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Histologically confirmed stage I-III primary rectal carcinoma;
- •Diagnosed between January 1st and June 30th of 2015;
- •TME resection of primary rectal carcinoma.
排除标准
- •Neuroendocrine tumor morphology;
结局指标
主要结局
Risk factors for development of locally recurrent rectal cancer in curatively treated primary rectal cancer patients
时间窗: Three years
UNIT OF MEASUREMENT: Risk factors for development of locally recurrent rectal cancer in primary rectal cancer patients MEASUREMENT TOOL: Registration of clinical and pathological covariates of primary rectal cancer in the electronic patient file and national pathological database (PALGA). Clinical and pathological risk factors for the development of locally recurrent rectal cancer will be identified using multivariable competing-risk risk regression analyses, according to the cause-specific hazard approach. This will inform on specific clinical and pathological covariates which increase or decrease the risk for development of locally recurrent rectal cancer.
Overall survival of patients with locally recurrent rectal cancer
时间窗: Three years
UNIT OF MEASUREMENT: Overall survival of patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of vital status in the national personal records database. Overall survival will be estimated for patients with locally recurrent rectal cancer, stratifying for different groups (i.e. treatment, diagnosis of synchronous metastases, diagnosis within first year after primary resection, etc.)
Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients
时间窗: Three years
UNIT OF MEASUREMENT: Cumulative incidence of patients with locally recurrent rectal cancer in curatively treated primary rectal cancer patients MEASUREMENT TOOL: Registration of diagnosis of locally recurrent rectal cancer in the electronic patient file. The competing-risk cumulative incidence will be calculated, which will inform on the proportion of patients who have developed locally recurrent rectal cancer at that time point.
Proportions of treatment given to patients with locally recurrent rectal cancer
时间窗: Three years
UNIT OF MEASUREMENT: Proportions of treatment given to patients with locally recurrent rectal cancer; MEASUREMENT TOOL: Registration of treatment for locally recurrent rectal cancer in the electronic patient file. Using descriptive statistics, treatment patterns of patients with locally recurrent rectal cancer will be identified. Groups that will be created, will also be used to assess overall survival.
次要结局
未报告次要终点
研究者
Hidde Swartjes
Researcher in training
Radboud University Medical Center