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治験 NCT07307547 (AI-COLOSCREEN)（対象：結腸直腸腫瘍、結腸ポリープ、腺腫、大腸がん）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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浙江大学Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN) 3,342 無作為化 多施設共同
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07307547 (AI-COLOSCREEN) は 介入研究 臨床試験 で、結腸直腸腫瘍、結腸ポリープ、腺腫、大腸がん に関するものです。現在は 募集準備中 で、2026年4月1日 に開始予定です。3,342 名の参加者 の募集が計画されています。この試験は 浙江大学 によって主導され、2028年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月10日 です。
概要
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...もっと見る
詳細説明
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...もっと見る
公式タイトル
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.
疾患名
結腸直腸腫瘍結腸ポリープ腺腫大腸がんその他の研究識別子
- AI-COLOSCREEN
- 2025-0756
NCT番号
開始日
2026-04
最終更新日
2026-02-10
終了予定日
2028-12
目標参加者数
3,342
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Artificial Intelligence
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
Colonoscopy
Colorectal Cancer Screening
Adenoma Detection Rate
Deep Learning
主目的
スクリーニング（選別）
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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. |
非介入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. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- 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.
浙江大学責任者
Ding Ke-Feng, 主任研究者, Clinical professor, Zhejiang University
試験中央連絡先
連絡先: Kefeng Ding, M.D., Ph.D., +86-13906504783, [email protected]
1 1カ国の場所
Zhejiang
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China
Kefeng Ding, M.D., Ph.D., 連絡先, +86-13906504783, [email protected]