Early screening for colorectal cancer via a simple blood sample

Not Applicable

• Conditions: Colorectal cancer; Cancer

• Registration Number: ISRCTN15583857
• Lead Sponsor: Centre Hospitalier Universitaire de Liège

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-26
• Last Update Posted: 12 December 2023
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified