Early screening for colorectal cancer via a simple blood sample

Early dynamic screening for colorectal cancer via novel protein biomarkers reflecting biological initiation mechanisms (DIOPTRA)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15583857

Enrollment

1600

Registered

2023-10-26

Start date

2024-01-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early screening of colorectal cancer from 18 to 80 years old Cancer

Interventions

Current interventions as of 08/08/2025: The study will be a prospective, cohort, multi-centre study with a partial follow-up of one year. Changes to the recruitment process throughout the duration o

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 25/06/2026: 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 between 18-80 years at the moment of recruitment 3. Absence of significant comorbidities (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 4 inclusion criteria here above 2. Patients willing to use the DIOPTRA application regularly 3. Level of digital literacy allows managing mobile terminals (smartphones, smartphone apps, tablets). 4. Good internet connection coverage at home 5. Availability of a smartphone/ tablet (to use the app) 6. Belonging to the healthy or non-advanced adenoma groups _____ Previous inclusion criteria as of 08/08/2025: 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 between 18-80 years at the moment of recruitment (see above) 3. Absence of significant comorbidities (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 4 inclusion criteria here above 2. Patients willing to use the DIOPTRA application regularly 3. Level of digital literacy allows managing mobile terminals (smartphones, smartphone apps, tablets) 4. Good internet connection coverage at home 5. Availability of a smartphone/ tablet (to use the app) 6. Belonging to the healthy or non-advanced adenoma groups _____ Previous participant inclusion criteria as of 09/01/2025: 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. Previously treated malignancy, other than CRC, if all treatment of that malignancy is completed at least 2 years before registration and the patient has no evidence of disease 3. Concurrent, clinically stable malignancy, other than CRC, without previous treatment, that does not require tumor-directed treatment 4. Age between 18-80 years at the moment of recruitment (see above) 5. Absence of significant comorbidities (ASA IV) 6. Ability to provide valid (written informed) consent 7. Boston-Bowel-Preparation-Scale (BBPS) left/transverse/right colon score =2, total score =6 Inclusion criteria for the follow-up study patients who will use the DIOPTRA mobile application: 1. Presenting the 4 inclusion criteria here above 2. Patients willing to use the DIOPTRA application regularly 3. Level of digital literacy allows managing mobile terminals (smartphones, smartphone apps, tablets) 4. Good internet connection coverage at home 5. Availability of a smartphone/ tablet (to use the app) 6. Belonging to the healthy or non-advanced adenoma groups _____ Previous participant 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 cri

Exclusion criteria

Exclusion criteria: Current key exclusion criteria as of 25/06/2026: 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 y/o or above 80 y/o 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) _____ Previous participant exclusion criteria as of 09/01/2025: 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 y/o or above 80 y/o 2. Comorbidities ASA IV 3. Any condition (e.g. prior major abdominal surgery, prior abdominal or pelvic radiation therapy) that in the endoscopist's opinion could predispose to incomplete colonoscopy 4. History of colectomy for reasons other than CRC 5. Malignancy other than CRC, completely treated in the last 2 years prior to the registration or with clinical evidence of disease 6. Concurrent malignancy, other than CRC, clinically unstable or requiring tumor-directed treatment 7. Inflammatory bowel diseases 8. Polyposis syndrome 9. Pregnancy or suspicion of pregnancy 10. Colorectal cancer history 11. BBPS left/transverse/right colon score <2, total score <6 12. 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) Previous participant 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)

Design outcomes

Primary

Measure	Time frame
Diagnostic sensitivity and specificity of DIOPTRA screening system in CRC detection measured using DIOPTRA variables with clinical diagnosis as reference (colonoscopy) at the end of the study	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 08/08/2025: 1. Diagnostic sensitivity diagnostic sensitivity for the detection of advanced adenomas measured using DIOPTRA variables at the end of the study. 2. Diagnostic sensitivity of the DIOPTRA screening system for detecting CRC or advanced adenoma, and specificity for detecting healthy and non-advanced adenoma groups in the sub-population without a prior history of malignancy or concurrent malignancy* measured using DIOPTRA variables at the end of the study 3. Model performance metrics of the DIOPTRA screening system measured using the prospective data for refinement at the end of the study 4. Risk factor difference and protein biomarker concentration measured with or without behavioural suggestion using mobile questionnaires and protein concentration quantification over the follow-up one-year period 5. Estimated efficiency of resources allocation of DIOPTRA screening system costs compared to screening colonoscopy. 6. Sensitivity and specificity of the blood-based immunoassay compared to the FIT test for detecting colorectal cancer and advanced adenomas. Prior history of malignancy or concurrent malignancy: Prior history of malignancy: other than CRC, if all treatment of that malignancy is completed at least 2 years before registration and the patient has no evidence of disease. Concurrent malignancy: Concurrent, clinically stable malignancy, other than CRC, without previous treatment, that does not require tumor-directed treatment. _____ Previous secondary outcome measures: 1. Diagnostic sensitivity and specificity of the DIOPTRA screening system for detecting advanced adenomas measured using DIOPTRA variables at the end of the study 2. Diagnostic sensitivity and specificity of the DIOPTRA screening system for detecting CRC in the sub-population without a prior history of malignancy or concurrent malignancy measured using DIOPTRA variables at the end of the study 3. Model performance metrics of the DIOPTRA scre	—

Measure

Time frame

Current secondary outcome measures as of 08/08/2025: 1. Diagnostic sensitivity diagnostic sensitivity for the detection of advanced adenomas measured using DIOPTRA variables at the end of the study. 2. Diagnostic sensitivity of the DIOPTRA screening system for detecting CRC or advanced adenoma, and specificity for detecting healthy and non-advanced adenoma groups in the sub-population without a prior history of malignancy or concurrent malignancy* measured using DIOPTRA variables at the end of the study 3. Model performance metrics of the DIOPTRA screening system measured using the prospective data for refinement at the end of the study 4. Risk factor difference and protein biomarker concentration measured with or without behavioural suggestion using mobile questionnaires and protein concentration quantification over the follow-up one-year period 5. Estimated efficiency of resources allocation of DIOPTRA screening system costs compared to screening colonoscopy. 6. Sensitivity and specificity of the blood-based immunoassay compared to the FIT test for detecting colorectal cancer and advanced adenomas. *Prior history of malignancy or concurrent malignancy: Prior history of malignancy: other than CRC, if all treatment of that malignancy is completed at least 2 years before registration and the patient has no evidence of disease. Concurrent malignancy: Concurrent, clinically stable malignancy, other than CRC, without previous treatment, that does not require tumor-directed treatment. _____ Previous secondary outcome measures: 1. Diagnostic sensitivity and specificity of the DIOPTRA screening system for detecting advanced adenomas measured using DIOPTRA variables at the end of the study 2. Diagnostic sensitivity and specificity of the DIOPTRA screening system for detecting CRC in the sub-population without a prior history of malignancy or concurrent malignancy* measured using DIOPTRA variables at the end of the study 3. Model performance metrics of the DIOPTRA scre

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Countries

Austria, Belgium, Croatia, Cyprus, Denmark, Greece, Slovenia, Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026