ISRCTN15583857进行中(未招募)Unknown
Early dynamic screening for colorectal cancer via novel protein biomarkers reflecting biological initiation mechanisms (DIOPTRA)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 入组人数
- 1,900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for prospective data collection and pilot evaluation:
- •1. Any indication for total colonoscopy (including routine screening and presence of symptoms/FIT positive)
- •2. Age 18-80 years at the moment of recruitment (see above)
- •3. Absence of significant comorbidities (American Society of Anesthesiologists [ASA] IV)
- •4. Ability to provide valid (written informed) consent
- •Inclusion criteria for the follow-up study patients who will use the DIOPTRA mobile application:
- •1. Presenting the four inclusion criteria above
- •2. Patients willing to use the DIOPTRA application regularly
- •3. Level of digital literacy allowing to manage mobile terminals (smartphones, smartphone apps, tablets)
- •4. Good coverage of internet connection at home
- •5. Availability of a smartphone/tablet (in order to be able to use the app)
- •6. Belonging to the healthy or non-advanced adenoma groups
排除标准
- •Persons belonging to the vulnerable group will not be included in the clinical study
- •Other exclusion criteria for the prospective study:
- •1. Age under 18 or above 80 years old
- •2. Comorbidities ASA IV
- •3. Recent major abdominal surgery (colectomy) or radiation prior to the recruitment
- •4. Inflammatory bowel diseases
- •5. Polyposis syndrome
- •6. Pregnancy or suspicion of pregnancy
- •7. Colorectal cancer history
- •8. Not able to understand the study and provide valid consent
- •Exclusion criteria for the follow-up study:
- •1. Classification in the CRC or advanced adenoma groups
- •2. Non-availability of a smartphone/tablet or inability to use a mobile app (e.g., due to low digital literacy)
研究者
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