CELTiC Trial: an International Multicentre Study Evaluating the CELTiC Panel for the Detection of Advanced Neoplasia in Fecal Immunochemical Test (FIT)-Positive Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 809
- 试验地点
- 8
- 主要终点
- Sensitivity of CELTiC
研究概览
简要总结
The CELTiC panel is a potential blood-based test for detecting colorectal cancer (CRC) and precursors of CRC. This can be useful for CRC screening, since this requires tests that detect cancer in an early stage to maximize the chances of successful treatment.
CELTiC combines four markers that can be detected in blood. These markers are composed of so-called messenger RNA (mRNA) and can be viewed as the instructions of our genes to the cell to make certain proteins. Cancer is the result of mutation in these genes. Thus, the mRNA in cancer patients is, depending on the type of mRNA, often abnormal. In earlier studies, the developers of CELTiC found four mRNA's that are different in patients with CRC compared to healthy individuals. However, CELTiC has not yet been extensively studied in individuals for whom the test is intended: a population undergoing CRC screening.
The current study aims to fill this gap. We will assess the ability of CELTiC to detect CRC and precursors of CRC in a population of individuals between 50 and 75 years old in the Netherlands and Italy. This population has already been preselected by having a positive fecal immunochemical test (FIT), a test that is frequently used in CRC screening. This population will undergo a colonoscopy, a procedure where a doctor enters the large bowel through the anus using a flexible camara to assess whether the patient has cancer. Prior to this colonoscopy, we will collect blood samples from the individuals to assess their CELTiC score. After the colonoscopy and the blood analysis, we can assess whether the test adequately detects CRC and precursors of CRC in this population.
详细描述
- BACKGROUND
Colorectal Cancer (CRC) is one of the leading causes of cancer in developed regions around the world and its incidence is rising(1,2). Many nations or regions have introduced CRC population screening programmes to detect cancerous lesions before symptoms arise or to detect precursor lesions whose eradication may prevent CRC (3).
The Faecal Immunochemical Test (FIT) is used to screen for CRC in many nations and regions around the world. Its advantages include ease of use, the ability to be performed at home and to be sent by mail to a laboratory, and its cost-efficiency (4). Moreover, these characteristics enable population-wide screening without the need for all participants to undergo a colonoscopy.
However, a downside of the FIT is its performance. In the Netherlands, where a FIT cut-off concentration of 47 mcg Hb/g faeces is used, the FIT produces a negative result in 15% of people who have CRC (5). For the detection of CRC and Advanced Adenomas (AA), referred to as Advanced Neoplasia (AN), the FIT falsely provides a negative result in up to 70% of people with AN. In addition, more than half of the people with a positive FIT result in the Netherlands do not have any (pre)cancerous lesions at colonoscopy.
One way to improve the efficiency of CRC screening is to introduce a second test to FIT-positive screening participants, to further select individuals for a colonoscopy. Ideally, this test should have a high sensitivity since a false negative result would lead to denying a colonoscopy to a FIT-positive individual with a (pre)cancerous lesion. In addition, the specificity of this test should be high enough to substantially reduce the number of FIT-positive individuals without AN undergoing colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Endoscopy staff will be blinded to the result of the CELTiC test. Additionally, laboratory staff that assesses the CELTiC test will be blinded to the result of the colonoscopy.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FIT concentration of 20 ug Hb/g or higher (Italy) or 47 ug Hb/g or higher (Netherlands) in the national CRC screening program as reason for referral.
- •Age between 55 and 75 years (Netherlands) or 50 and 69 years (Italy)
排除标准
- •No signed informed consent
- •History or current treatment for colorectal cancer
- •History of inflammatory bowel disease
- •History of other condition for which colonoscopy surveillance is planned within the next 5 years.
结局指标
主要结局
Sensitivity of CELTiC
时间窗: AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.
The sensitivity of the CELTiC test for detecting advanced neoplasia
次要结局
- Specificity of CELTiC(AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.)
- C-statistic of CELTiC(AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.)
- Positive Predictive Value of CELTiC(AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.)
研究者
Prof. Evelien Dekker, MD, PhD
Professor doctor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)