Colorectal cancer Bowel cancer
Conditions
Interventions
An AI-system (CADx) which will be capable of diagnosing T1 CRCs, estimating invasion depth of CRC and which includes an algorithm-based treatment advise. 
Sponsors
Catharina Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 18 years or olderAble to give informed consentThe patient has a planned colonoscopy for the endoscopic resection of a known large colorectal polyp or a suspected colorectal malignancy.
Exclusion criteria
Exclusion criteria: Patients with inadequate bowel preparations after adequate washing, suctioning and other cleaning manoeuvres have been performed by the endoscopist: BPPS 1 or 2 in the segment of the polyp or carcinoma. The BPPS of the other segments is not explicitly graded. Patient with an active IBD in the same segment as the polyp or carcinoma.Patient with familial adenomatous polyposis (FAP)Patients who have a written objection in their patient file for participation in scientific research.Patients with a recurrence of a polyp or malignancy after earlier resection.When a biopsy of the lesion has occurred before video of the lesion is performed.No pathology of the lesion is obtained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the CADx system regarding interface, latency and the absence of technical flaws. | — |
Secondary
| Measure | Time frame |
|---|---|
| The diagnostic performance of the CADx system compared to the diagnostic performance of endoscopists, using histopathology as gold standard. Diagnostic performance will be measured as sensitivity, specificity, negative predictive value, positive predictive value, diagnostic accuracy and the area under the ROC curve.Accuracy of the CADx system in estimating the invasion depth, using histopathology as gold standard.Evaluating if the CADx system is capable of providing an accurate treatment advice compared to the most appropriate treatment based on histopathology, lesion location, and lesion size. | — |
Countries
Netherlands
Contacts
Public ContactE.J. Schoon
Catharina Ziekenhuis
Outcome results
None listed