SCREESCO - Screening of Swedish Colons
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 278,000
- 主要终点
- Mortality from colorectal cancer in the Swedish population.
研究概览
简要总结
Colorectal cancer (CRC) is a major cause of death in Sweden. There are approximately 6000 new cases each year in Sweden and the disease specific mortality is more than 40%. There risk is about 1% to develop CRC between 60-70 years of age making 60-year olds a suitable target population for colorectal cancer screening.
The Swedish ministry of health and social affairs proposed a national study on the efficiency of colorectal cancer screening in the Swedish population regarding mortality, but also what screening method to be used. Eighteen participating counties of Sweden now fund the study to be launched in 2014.
From the Register of the total population individuals 59-62 years of age will be randomized and invited by mail to screening. Thirty- thousand five hundred individuals will be invited to primary colonoscopy and 60 000 individuals will be invited to high sensitive FIT (approximately 10% positive) and if positive to a subsequent follow-up colonoscopy. If test negative a second round of FIT will be asked for in two years. In total 183 000 randomized individuals will not be invited to screening, but followed in the Swedish Cancer register and serve as controls. The inclusion period I set to five years (five years with the second round of FIT) generating approximately 5 000 colonoscopies yearly the first three years and 1200 year four and five at a compliance rate of 35% in the colonoscopy arm and 50% in the FIT arm.
Follow-up time is set to 15 years with the primary endpoint disease specific mortality, but also incidence. Secondary outcomes by others to be studied are in short quality assurance variables of colonoscopy, participants and non-participants experiences of the invitation and the screening procedure, health economy measures of the CRC-screening study and when implemented in clinical care.
详细描述
Background: The primary purpose of cancer screening is to reduce mortality from the disease in the population by finding the cancer at an early and treatable stage. The cancer has to be an important health problem to be a suitable target for screening. With approximately 6 000 new cases each year in Sweden (Cancer register), colorectal cancer (CRC) is the third most common cancer in Sweden and the five-year survival rate is close to 60%, but when detected at an early stage the rate is 90%.
Both larger precursor stages - the adenomatous polyp (Muto, Vogelstein) - and cancers could be detected by sensitive methods to analyze blood in the stool. Removal of adenomas has a protective effect against colorectal cancer development (Winawer, Muller, Thiis-Evensen) and, consequentially, a colorectal cancer screening program also have the potential of decreasing the future incidence of the disease.
The screening test must be free from unwanted side effects, inexpensive, but also simple to take and easy to interpret (Armitage). Furthermore, a high sensitivity and specificity is a prerequisite for a screening test to be used in a program of the average risk population.
Indirect tests: The most commonly used screening test has been the guaiac based fecal occult blood test (Hemoccult®). Four larger RCTs have demonstrated a 16% decreased in CRC mortality with the test in screening (Mandel, Kronborg, Hardcastle, Lindholm). More advanced fecal immunological tests (FITs) with higher sensitivity, but only a marginally increase in specificity, are now available. FIT demonstrates presence of human blood only and no dietary restrictions are needed.
Direct tests: The main advantages with endoscopy are the direct visualization of the colorectum and the possibility of obtaining tissue samples from suspected cancer lesions for histopathology and removing adenomatous polyps. Recently, three RCTs with sigmoidoscopy as the primary screening test have demonstrated both a reduced disease specific mortality of around 30%, but also a reduced incidence of CRC of as much as 40% (Atkin, Segnan, Schoen).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 59 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People 59-62 years old living in Sweden randomized and identified through the Register of the total population.
排除标准
- •Residents of the counties of Stockholm, Gotland and Västernorrland, individuals with diagnosed with colorectal cancer and/or anal cancer, and individuals randomized to be included in the ongoing NordICC-trial.
结局指标
主要结局
Mortality from colorectal cancer in the Swedish population.
时间窗: 15 years follow-up
次要结局
- Incidence of colorectal cancer in the Swedish population.(15 years follow-up)
- To study compliance with the screening program (read study) and what factors are of importance for the adherence rate.(1-5 years)
- To study health economy and costs for colorectal cancer screening.(1-20 years)
- To study the emotional impact of screening on participants and non-participants including eventual change in lifestyle after invitation and/or participation.(1-5 years)
- To study surveillance strategies for adenomas found at colonoscopy.(1-20 years)
- To study associations of DNA in blood with findings at colonoscopy.(1-20 years)
- To study the flora of fecal bacteria among participants and outcome of FIT and colonoscopy.(1-5 years)
- To study quality control aspects and side effects of screening with colonoscopy.(1-5 years)
- To study pathology by means of quality registries and digital pathology.(1-5 years)
研究者
Anna Forsberg
Associate Professor
Karolinska Institutet