Impact of a Digital Training Program (Colo-ID) on Optical Histologic Prediction and Management of Colorectal Polyps: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Change in Optical Histology Prediction Accuracy After Use of the Colo-ID Training Program
研究概览
简要总结
Colorectal cancer prevention relies on high-quality colonoscopy and accurate optical characterization of colorectal polyps. Optical diagnosis may allow optimization of management strategies such as resect-and-discard for diminutive polyps, potentially improving efficiency in routine practice.
COLO-PREDICT is a prospective, single-center, observational study designed to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histology prediction of colorectal polyps in real-life clinical practice.
All consecutive adult patients undergoing colonoscopy with at least one detected polyp will be included. Optical prediction of polyp histology will be recorded during the procedure. All polyps will be resected and sent for histopathological analysis according to standard practice. No modification of patient management will occur as part of the study.
The primary objective is to assess the concordance between optical prediction and histopathology before and after implementation of the digital training program. Secondary objectives include evaluation of prediction performance according to polyp characteristics and assessment of potential implications for clinical practice.
详细描述
Colorectal cancer (CRC) prevention depends on the detection and removal of precursor lesions during colonoscopy. Optical diagnosis of colorectal polyps using enhanced imaging technologies has been proposed to improve procedural efficiency and to potentially support management strategies such as resect-and-discard for diminutive lesions. However, variability in optical characterization accuracy remains a major limitation in routine practice.
COLO-PREDICT is a prospective, single-center, observational study conducted in real-life clinical practice. The study aims to evaluate the impact of a structured digital training program (Colo-ID, a digital application for colonic polyp characterisation training) on the accuracy of optical histologic prediction of colorectal polyps.
Adult patients undergoing colonoscopy with at least one detected polyp will be consecutively included. During each procedure, the endoscopist will record an optical prediction of polyp histology based on standard classification systems and routine imaging modalities. All polyps will be resected and submitted for histopathological examination in accordance with current standard of care. No modification of patient management, surveillance interval, or therapeutic strategy will be implemented as part of the study.
The digital training program consists of a structured educational intervention focused on optical characterization principles, image-based training, and performance assessment in a simulated environment. The study evaluates optical prediction performance before and after implementation of this training program in routine practice.
The primary endpoint is the rate of concordance between optical histologic prediction and final histopathology. Secondary endpoints include diagnostic performance parameters (sensitivity, specificity, positive predictive value, negative predictive value), performance according to polyp size and location, and assessment of potential implications for clinical practice efficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years
- •Patients undergoing colonoscopy in routine clinical practice at the participating center
- •At least one colorectal polyp detected during colonoscopy
- •Optical histology prediction recorded during the procedure
- •Histopathological analysis available for resected polyps (reference standard)
排除标准
- •Patients aged <18 years
- •Refusal/opposition to use of data (if applicable under local regulations)
- •Missing key study data (e.g., no recorded optical prediction or no histopathology result)
研究组 & 干预措施
Prospective Colonoscopy Cohort
Adult patients undergoing colonoscopy with at least one detected colorectal polyp. Optical histology prediction is recorded during routine clinical practice. All polyps are resected and sent for histopathological analysis according to standard care. No modification of patient management is performed as part of the study.
干预措施: Digital Training Program (Colo-ID) (Other)
结局指标
主要结局
Change in Optical Histology Prediction Accuracy After Use of the Colo-ID Training Program
时间窗: Pre-training period and post-training period between February 2026 and June 2026.
Difference in overall accuracy of optical histologic prediction of colorectal polyps (agreement with final histopathology) between the pre-training period and the post-training period following implementation of the Colo-ID training program in routine clinical practice.
次要结局
- Proportion of Polyps Eligible for Resect-and-Discard and Diagnose-and-Leave Strategies(From February 2026 to June 2026.)
- Proportion of Advanced Lesions Among Polyps Considered Eligible for Discard(From February 2026 to June 2026.)
- Inter-Operator Variability in Optical Prediction Accuracy(Pre- and post-training periods between February 2026 and June 2026.)
- Individual and Collective Performance Evolution After Training(Pre- and post-training periods between February 2026 and June 2026.)
- Estimated Potential Cost and Environmental Savings Associated With Resect-and-Discard and Diagnose-and-Leave Strategies Eligibility(End of study analysis (June 2026).)
- Change in Questionnaire Score Assessing Confidence, Knowledge, and Readiness to Implement Resect-and-Discard and Diagnose-and-Leave Strategies(Pre-training and post-training (within February 2026 to June 2026).)