评估计算机辅助检测在筛查性结肠镜检查中降低3年内进展期腺瘤风险的随机对照试验。 (IA-COLO 2)
评估计算机辅助诊断在筛查性结肠镜检查中降低3年内进展期腺瘤风险的随机对照试验。
The occurrence of interval cancers after colonoscopy raises the possibility of missed lesions. High- performance computer aided diagnosis (CAD) systems have been specially designed for the detection of colorectal lesions (CAD for detection is named CADe). The use of CADe improves adenoma detection in screening colonoscopy. The potential of CADe system in reducing the rate of progression to advanced polyps or interval cancer between two colonoscopies remains still uncertain.
研究概览
详细说明
Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Randomization into two groups: standard colonoscopy vs. colonoscopy with CADe (CAD EYE or GENIUS) (1:1). A follow-up consultation will be scheduled one-month postcolonoscopy for delivery of histological results and then at 3 years in order to organize the next colonoscopy. As part of the study, a new control colonoscopy will be scheduled for patients with high risk of CRC at 3 years. The 3-year control colonoscopy will be performed with the CAD system for all patients. The colonoscopy will be performed by another investigator who does not know the results nor the type of the first colonoscopy (evaluator blinded). In the low-risk group, we will collect follow-up data as part of routine care, including the results of colonoscopies performed outside of the protocol
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Arthur BERGER, MD
- 电话号码：+335 57 67 49 31
- 邮箱：arthur.berger@chu-bordeaux.fr
学习地点
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Bayonne、法国、64100
- 尚未招聘
- CH de la Côte Basque
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接触：
- Felix GOUTORBE, MD
- 电话号码：+33 5.59.44.31.36
- 邮箱：f.goutorbe@ch-cotebasque.fr
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首席研究员：
- Félix GOUTORBE, MD
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Brest、法国、29200
- 尚未招聘
- CHU Brest la Cavale Blanche
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接触：
- Lucille QUENEHERVE, MD
- 电话号码：+332.98.34.71.16
- 邮箱：lucille.queneherve@chu-brest.fr
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首席研究员：
- Lucille QUENEHERVE, MD
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Carhaix-Plouguer、法国、29270
- 尚未招聘
- Hôpital de Carhaix
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接触：
- Rubeshen Pillay ARNACHELUM, MD
- 邮箱：rubeshen-pillay.arnachellum@chu-brest.fr
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首席研究员：
- Rubeshen Pillay ARNACHELUM
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Charenton-le-Pont、法国、94220
- 尚未招聘
- Clinique Paris Bercy
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接触：
- David KARSENTI, MD
- 电话号码：+331.43.96.78.34
- 邮箱：karsenti.paris@gmail.com
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首席研究员：
- David KARSENTI, MD
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Limoges、法国、87042
- 尚未招聘
- CHU de Limoges
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接触：
- Rémi COLLIN, MD
- 电话号码：+335.55.05.55.55
- 邮箱：remi.collin@chu-limoges.com
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首席研究员：
- Rémi COLLIN, MD
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Marseille、法国、13009
- 尚未招聘
- Institut Paoli Calmettes
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首席研究员：
- Jean-Philippe RATONE, MD
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接触：
- Jean-Philippe RATONE, MD
- 电话号码：+334 91 22 35 68
- 邮箱：ratonej@ipc.unicancer.fr
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Nantes、法国、44300
- 尚未招聘
- Clinique Jules Verne
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接触：
- Bertrand BRIEAU, MD
- 电话号码：+332.51.17.34.00
- 邮箱：bertrand.brieau@gmail.com
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首席研究员：
- Bertrand BRIEAU, MD
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Nîmes、法国、30029
- 尚未招聘
- CHU Nîmes
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首席研究员：
- Ludovic CAILLO, MD
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接触：
- Ludovic CAILLO, MD
- 电话号码：+334.66.68.31.83
- 邮箱：ludovic.caillo@chu-nimes.fr
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Paris、法国、75020
- 尚未招聘
- APHP - Hôpital Tenon
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接触：
- Antoine GUILLOUX, MD
- 电话号码：+331.56.01.63.16
- 邮箱：antoine.guilloux@aphp.fr
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首席研究员：
- Antoine GUILLOUX, MD
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Paris、法国、75015
- 尚未招聘
- Aphp-Hegp
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接触：
- Guillaume PERROD, MD
- 电话号码：+331.56.09.57.00
- 邮箱：guillaume.perrod@aphp.fr
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首席研究员：
- Guillaume PERROD, MD
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Paris、法国、75012
- 尚未招聘
- APHP - Hôpital Saint Antoine
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接触：
- Xavier DRAY, MD
- 电话号码：+331.49.28.27.10
- 邮箱：xavier.dray@aphp.fr
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首席研究员：
- Xavier DRAY, MD
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Pessac、法国、33604
- 招聘中
- CHU Bordeaux - Hôpital Haut Lévêque
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首席研究员：
- Arthur BERGER, MD
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接触：
- Arthur BERGER, MD
- 电话号码：+335 57 67 49 31
- 邮箱：arthur.berger@chu-bordeaux.fr
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Rennes、法国、35000
- 尚未招聘
- CHU de Rennes
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首席研究员：
- Timothée WALLENHORST, MD
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接触：
- Timothée WALLENHORST, MD
- 电话号码：+332.99.28.43.21
- 邮箱：timothee.wallenhorst@chu-rennes.fr
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Toulouse、法国、31076
- 尚未招聘
- Clinique Pasteur
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接触：
- Mathieu GUIVARCH, MD
- 电话号码：+331.49.28.27.10
- 邮箱：mguivarch@clinique-pasteur.com
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首席研究员：
- Mathieu GUIVARCH, MD
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Vandœuvre-lès-Nancy、法国、54511
- 尚未招聘
- CHRU de Nancy - Hôpital Brabois Adultes
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接触：
- Marion SCHAEFER, MD
- 电话号码：+333.83.15.41.49
- 邮箱：m.schaefer@chru-nancy.fr
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首席研究员：
- Marion SCHAEFER, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients over 18 years of age with indication for colonoscopy as part of a screening program, after a positive immunological (FIT) test, and/or for personal or family history of colorectal cancer and/or personal history of colonic adenomas and/or sessile serrated polyp,
- Written informed consent signed
- Patients covered by a health-care insurance.
Exclusion Criteria:
- Failed complete colonoscopy, defined by the absence of cecal intubation or identification of the terminal ileum.
- Inadequate bowel preparation (Boston bowel preparation score < 6, and/or least at one part of colon with score ≤ 1)
- An infiltrative tumor was diagnosed during colonoscope insertion time, not accessible to endoscopic resection and likely to require surgical management (a procedure where part of the colon may need to be removed).
- Patient under guardianship or protection
- Pregnant women
- Not fluent in French or illiterate
- Personal history of inflammatory bowel disease
- Personal history of genetic predisposition of CRC
- Personal history of major colorectal surgery involving total or subtotal colectomy
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Standard colonoscopy
Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has standard colonoscopy |
Colonoscopy standard (without CADe) |
|
有源比较器：Colonoscopy with CADe
Patients will be enrolled after a pre-colonoscopy consultation and risk-assessment for colorectal cancer. The screening colonoscopy will be performed by an investigator. Patients will be randomized in the endoscopy room after confirmed cecal intubation and quality of bowel preparation. Patient has colonoscopy with CADe (CAD EYE or GENIUS) |
colonoscopy with CADe |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Advanced adenoma
大体时间：36 months
|
The proportion of patients presenting at least one advanced adenoma detected after a 3-year follow-up period. An advanced adenoma is defined as an adenoma or sessile serrate adenoma (SSL) larger than 1cm (size confirmed by the CAD system and/or size estimation by snare), and/or with high-grade dysplasia or neoplasia (confirmed by histological analysis). |
36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of adenoma
大体时间：36 months
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Average number of adenoma or SSL (confirmed by histological analysis) detected in each patient during screening colonoscopy after a 3-year follow-up period |
36 months
|
|
Estimation of the sensitivity of CADx
大体时间：Day0, 36 months
|
Estimated sensitivity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis. |
Day0, 36 months
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Estimation of the specificity of CADx
大体时间：DAY 0, 36 months
|
Estimated specificity of CADx (CAD for characterization is named CADx) for the diagnosis and evaluation of colonic polyp's malignancy, with histologic analysis in each center as a reference diagnosis. |
DAY 0, 36 months
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Cost of CADe and classical colonoscopy
大体时间：Day 0, 36 months
|
The cost of CADe and classical colonoscopy will be estimated using a bottom-up micro costing approach |
Day 0, 36 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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