Evaluating a computer-aided colonoscopy for detecting colorectal cancer
Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.
This study is testing if a computer-assisted colonoscopy can find more polyps in people aged 40 to 80 than the regular colonoscopy during screening for colorectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei city) |
| Trial ID | NCT05240625 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of a computer-aided detection (CADe) system against standard colonoscopy in identifying adenomas during screening for colorectal cancer. Participants aged 40 to 80, scheduled for colonoscopy, will be randomly assigned to receive either the CADe-assisted colonoscopy or the standard procedure. The study aims to measure the adenoma detection rate (ADR) as a key quality indicator, utilizing advanced AI algorithms to enhance the detection of colonic lesions. Histological examinations of resected polyps will be conducted by blinded pathologists to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 80 who are scheduled for screening or diagnostic colonoscopy.
Not a fit: Patients with contraindications to colonoscopy, inflammatory bowel disease, or a history of colorectal cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the detection rates of colorectal cancer and adenomas, potentially reducing cancer-related deaths.
How similar studies have performed: Previous studies have shown that computer-aided detection systems can significantly improve adenoma detection rates, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who have given signed informed consent form * Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found * Subjects who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up Exclusion Criteria: * Subjects with any of the following prior history or current conditions: 1. Contraindications to colonoscopy 2. Inflammatory bowel disease (IBD) 3. Colorectal cancer (CRC) 4. Familial adenomatous polyposis (FAP) 5. Colonic stenosis 6. Severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D) 7. Active gastrointestinal (GI) Bleeding 8. Pregnancy 9. Prior colorectal surgery, including colonic or rectal resection (except for appendectomy, surgery on the anus, and polypectomy) 10. Undergo colonoscopy within 3 years * Subjects with any of the following conditions per the investigator's judgement: 1. High suspicion of IBD, CRC, and FAP. 2. High risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet medication.
Where this trial is running
Taipei city
- National Taiwan University Hospital — Taipei city, Taiwan (Recruiting)
Study contacts
- Study coordinator: Han-Mo Chiu, MD, PhD
- Email: hanmochiu@ntu.edu.tw
- Phone: +886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.