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临床试验 NCT07307547 (AI-COLOSCREEN) 针对结直肠肿瘤，结肠息肉，腺瘤，结直肠癌目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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浙江大学Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN) 3,342 随机化 多中心
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07307547 (AI-COLOSCREEN)是一项针对结直肠肿瘤，结肠息肉，腺瘤，结直肠癌的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年4月1日开始，预计招募3,342名患者。该研究由浙江大学主导，计划于2028年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月10日。
简要概括
This study is a multi-center, randomized controlled trial designed to evaluate whether an artificial intelligence (AI) system can assist endoscopists to improve the detection rate of colorectal adenomas and cancers during colonoscopy compared to standard colonoscopy. Early screening and diagnosis are key to reducing the burden of colorectal cancer, but current colonoscopy has limitations, including the risk of missed...显示更多
详细描述
Colorectal cancer (CRC) screening is crucial for early detection and reducing mortality, yet current colonoscopy techniques face challenges such as variable adenoma detection rates (ADR) and the risk of missed diagnoses for subtle lesions. This study is a prospective, multi-center, parallel-group, randomized controlled trial aiming to validate the clinical value of an AI-assisted diagnostic system in improving screen...显示更多
官方标题
A Multi-center, Randomized, Controlled Clinical Study on the Efficacy of Artificial Intelligence-Assisted Colonoscopy in Improving the Screening of Colorectal Cancer and Precancerous Lesions.
疾病
结直肠肿瘤结肠息肉腺瘤结直肠癌其他研究标识符
- AI-COLOSCREEN
- 2025-0756
NCT编号
实际开始日期
2026-04
最近更新发布
2026-02-10
预计完成日期
2028-12
计划入组人数
3,342
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
Artificial Intelligence
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
主要目的
筛查
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Experimental: AI-Assisted Colonoscopy Participants will undergo a high-definition colonoscopy procedure where a real-time artificial intelligence system analyzes the video feed to assist the endoscopist in identifying and highlighting suspicious lesions. | AI-Assisted Colonoscopy High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system. |
无干预Control: Conventional Colonoscopy Participants will undergo a standard high-definition colonoscopy procedure performed by a qualified endoscopist without the assistance of the artificial intelligence system. The AI software will not be active during these procedures. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Adenoma Detection Rate (ADR) | The proportion of participants with at least one histologically confirmed colorectal adenoma or adenocarcinoma. Detection and specimen collection occur during the colonoscopy, with final confirmation based on pathology reports. | From the day of the procedure up to 14 days post-procedure. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Mean Adenomas Per Colonoscopy (APC) | The mean number of histologically confirmed adenomas detected per participant. The number of polyps is counted during the procedure, but confirmation of adenoma status depends on pathology. | From the day of the procedure up to 14 days post-procedure. |
Advanced Adenoma and Sessile Serrated Adenoma/Polyp (SSA/P) Detection Rate | The proportion of participants with at least one histologically confirmed advanced adenoma (defined as ≥10mm, or with high-grade dysplasia or villous components) or SSA/P. | From the day of the procedure up to 14 days post-procedure. |
Patient Satisfaction Score | Assessed using a 5-point Likert scale questionnaire evaluating examination comfort and acceptance of the AI system (1=very unsatisfied, 5=very satisfied). | Assessed within 1 hour after completion of the colonoscopy procedure. |
Physician Satisfaction Score | Assessed using a 5-point Likert scale questionnaire evaluating the AI system's usability and reliability (1=very unsatisfied, 5=very satisfied). | Assessed within 1 hour after completion of the colonoscopy procedure. |
Incidence of Procedure-Related Adverse Events | The number and type of adverse events (AEs) and serious adverse events (SAEs), including but not limited to perforation, significant bleeding, and infection, are recorded. | From the start of the procedure up to 30 days post-procedure. |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Age between 18 and 75 years, inclusive.
- Scheduled for a screening, diagnostic, or surveillance colonoscopy.
- Able to understand the study protocol and provide written informed consent.
- Known contraindications to colonoscopy or biopsy.
- Personal history of colorectal cancer, inflammatory bowel disease (IBD), or previous colorectal surgery.
- Known or suspected colorectal polyposis syndrome (e.g., Familial Adenomatous Polyposis - FAP).
- Patients with active colorectal bleeding, bowel obstruction, or toxic megacolon.
- Women who are pregnant, planning to become pregnant, or are breastfeeding.
- Participation in another interventional clinical trial within the 30 days prior to enrollment.
- Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
浙江大学研究责任方
Ding Ke-Feng, 主要研究者, Clinical professor, Zhejiang University
研究中心联系人
联系人: Kefeng Ding, M.D., Ph.D., +86-13906504783, [email protected]
1 位于 1 个国家/地区的研究中心
Zhejiang
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Kefeng Ding, M.D., Ph.D., 联系人, +86-13906504783, [email protected]