Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Colorectal Cancer Stage (pTNM)
研究概览
简要总结
The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after immunochemical based faecal occult blood test) has more favourable clinical-pathological characteristics than colorectal cancer diagnosed for symptoms. We aimed to compare these two groups of patients at the time of diagnosis and confirm the efficiency of the screening programme.
详细描述
Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee.
All participants gave their informed signed consent. Each centre was assigned a unique ID number to distinguish between the locations in which patients were enrolled.
Patients informations were stored under identification number in secure internet database (RedCap) run by The International Clinical Research Center of St. Anne's University Hospital Brno.REDCap is a secure, web-based application designed to support data capture for research studies.
Statistical analysis was done with SAS, ver. 9.3. Descriptive statistics such as absolute and relative frequencies and median with 95 % confidence intervals were used. Differences between the screening and non-screening groups were compared using the Chi-square test or Fisher's exact test (categorical parameters) and Mann-Whitney test (continuous parameters). Results with a p-value < 0.05 were considered statistically significant
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed colorectal cancer
排除标准
- •unsigned informed consent
- •mental disorder
结局指标
主要结局
Colorectal Cancer Stage (pTNM)
时间窗: at time of diagnosis
Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group. * 0. stage (Tis N0 M0) * I. stage (T1-2 N0 M0) * II. stage (T3-4 N0 M0) * III. stage (T1-4 N1-2 M0) * IV. stage (T1-4 N1-2 M1) Stages 0,I II were considered to have better outcome
次要结局
- Colorectal Cancer Grade(after surgery was performed)
- Colorectal Cancer Surgery(time between diagnosis and surgery, measured after surgery was performed)
- Colorectal Cancer and Palliative Therapy(during treatment plan setting)
- Colorectal Cancer Resection Margins(after surgery was performed)
- Colorectal Cancer Metastasis(at time of diagnosis)
研究者
Jan Král, MD
M.D.
Institute for Clinical and Experimental Medicine