Acceptability and Effectiveness of Colonography Compared to Colonoscopy for the Detection of Advanced Adenomas in Patients at High Risk for Colorectal Cancer
概览
- 阶段
- 不适用
- 干预措施
- CT-colonography
- 疾病 / 适应症
- Colorectal Cancer
- 发起方
- Assistance Publique - Hôpitaux de Paris
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Percentage of patients who refuse to undergo an examination
- 状态
- 终止
- 最后更新
- 上个月
概览
简要总结
to evaluate the acceptability of CT-colonography compared to colonoscopy for the detection of advanced adenomas in subpopulations at high risk of colorectal.
详细描述
Secondary objective: to evaluate the medical and economic impact of the implementation of CT- colonography in this setting.Methodology: prospective multicenter randomized controlled trial with direct patient benefitN° of patients to be included: 600 Study follow-up :1 consultation and 3 phone contacts (M1, M6 and M12)Evaluation criteria:Main endpoint: acceptability of the colorectal cancer screening (% of enrolled patients having actually undergone the exploration)Secondary endpoints: - cost/effectiveness ratio of the 2 diagnostic tests with calculation of the economic and medical costs. - number of advanced adenoma detected in each group- number of CRC cases detected in each group
研究者
入排标准
入选标准
- •Surveillance of patients with a personal history of advanced adenoma or CRC:
- •Informed consent obtained
- •Age ≥ 18 and ≤ 80 years old
- •History of advanced adenomatous polyps
- •Or history of non metastatic CRC with curative surgery and without other treatment more than 2 years before enrollment.
- •Previous medical examination
- •Screening of patients with a Family history of CRC at high risk:
- •Informed consent obtained
- •Age ≥ 18 and ≤ 80 years old
- •First degree family history of colorectal cancer diagnosed \<60yrs during the five previous years-Previous medical examination
排除标准
- •Personal histories
- •Age \< 18 or \>80 years old
- •history of non adenomatous polyps
- •history of Metastatic CRC
- •familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis colorectal cancer (HNPCC), juvenile polyposis syndrome
- •Familial history of familial adenomatous polyposis
- •Personal history of subtotal colectomy (but not of hemicolectomy, to confer to inclusion criteria)
- •Colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment.
- •Enrollment in another protocol
- •no health insurance affiliation Family histories
研究组 & 干预措施
1
CT Colonography
干预措施: CT-colonography
2
Colonoscopy
干预措施: Colonoscopy
结局指标
主要结局
Percentage of patients who refuse to undergo an examination
时间窗: 36 months