Colorectal cancer
Conditions
Interventions
Forward looking section:None
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase 1: 1.Healthy normal individuals clinically confirmed to have no organic intestinal lesions. 2.Patients with pathologically confirmed benign or malignant colorectal tumors, and patients with benign or malignant colonic lesions confirmed by endoscopic biopsy. 3.Have undergone abdominal CT covering the entire abdomen or mid-lower abdomen within 1 year prior to surgery or pre-biopsy (if multiple examinations are available, the most recent one should be used). Phase 2: 1.Age >=18 years, any gender. 2.Subjects who undergo whole-abdomen or mid-lower abdomen non-contrast CT in outpatient clinics, emergency departments, inpatient wards, or health examination centers.
Exclusion criteria
Exclusion criteria: Phase 1: 1.Have undergone colorectal surgery or received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, targeted therapy) prior to CT examination. 2.Presence of other tissue lesions or foreign bodies that interfere with colonic imaging evaluation. 3.Poor quality of CT images. Phase 2: 1.Previously confirmed history of colorectal cancer or prior treatment for colorectal tumors. 2.Presence of acute intestinal obstruction, gastrointestinal perforation, severe acute enteritis, or other critical illnesses that contraindicate colonoscopy. 3.Non-contrast CT reconstructed slice thickness >5 mm, or abdominal CT images with motion artifacts or metal artifacts that preclude evaluation. 4.Presence of absolute contraindications to colonoscopy or biopsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Area Under the ROC Curve (AUC);Positive Predictive Value (PPV); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of early-stage (Stage I–II) colorectal cancer;Health economic evaluation: Incremental cost-effectiveness ratio (ICER) of non-contrast CT opportunistic screening combined with targeted colonoscopy intervention.;Overall compliance rate for initial and sequential recalls; | — |
Countries
China
Contacts
Public ContactKai Cao
Shanghai Changhai Hospital
Outcome results
None listed