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临床试验/NCT02596113
NCT02596113已完成不适用

Νew Molecular Biomarkers for the Prevention and Early Detection of Precancerous or Cancerous Colorectal Lesions During Screening for Colorectal Cancer

Evangelismos Hospital1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with no endoscopic findings

研究概览

简要总结

The investigators designed a prospective study to evaluate the predictive ability of detection of mutations in genes involved in carcinogenesis of the colon (eg hMLH1, K-Ras, B-Raf, ccfDNA) in a sample of Greek population presents for conducting colonoscopy in the context of screening under international CRC prevention instructions. This investigation will be carried out in individuals in normal risk in order to study specific mutations (in blood and tissue) to draw reliable conclusions about whether we can detect (with greater sensitivity and specificity) patients with precancerous lesions or CRC with a simple blood test thereby reducing the cost and side effects of repeated endoscopic procedures.

详细描述

Colorectal cancer (CRC) is the third most frequent cancer worldwide with a prevalence of 1.5 million people / year and is the second cause of death from cancer (650 000 deaths per year) for both genders after lung cancer.

In Greece it is estimated that about 3000 people are infected annually by the CRC. Risk factors for the emergence of CRC are: old age, positive family history of cancer and colon polyps, diet poor in fiber and rich in high-calorie fats and foods, sedentary lifestyle and lack of exercise from everyday life. Additionally, obesity, smoking, alcohol consumption in large quantities, diabetes, inflammatory conditions of the intestine such as ulcerative colitis and Crohn's Crohn, and some inherited disorders affecting colon are factors that increase the risk for the CRC.

It is a silent and insidious disease since most patients do not present symptoms in the early stages (such as bleeding, abdominal pain), resulting in diagnosis in a non-curable phase. This makes it clear that survival depends on the stage of disease at time of diagnosis. For example a patient with cancer Dukes' stage A, 5-year survival is about 93% whereas stage C, is about 47%. Based on the above it is clear that early detection of precancerous colorectal lesions is the cornerstone for the optimal treatment of this disease.

The CRC is an ideally disease to implement mass screening in general population as it follows a specific development process that lasts 7-12 years, leading to transformation of normal epithelium to adenoma and eventually carcinoma.

There are multiple options available for CRC detection involving the detection of blood in fecal test (or microscopic examination of fecal hemoglobin), the flexible sigmoidoscopy and colonoscopy. Each of these has advantages and disadvantages. Specifically, the microscopic examination of fecal hemoglobin although reduces mortality by 16% by CRC nevertheless exhibits low sensitivity to detect polyps and cancerous lesions in the distal colon and small specificity thus be, in economic terms, negative test to be used in mass screening. Regarding the flexible sigmoidoscopy, this is a test clearly faster and safer than colonoscopy but with small percentage of patient compliance, efficacy clear depended on the quality of bowel preparation and most importantly, it can not see the whole intestine. Computed tomographic colonography is another method of finding new precancerous lesions but because of the short diagnostic accuracy compared to the colonoscopy and radiation, is not recommended for mass screening.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • normal risk for developing CRC aged 50-75 years who undergo preventive colonoscopy for polyps and CRC detection

排除标准

  • 未提供

结局指标

主要结局

Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with no endoscopic findings

时间窗: 1 month

Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with adenomatous polyp bigger than 1 cm

时间窗: 1 month

Genes' mutations rate in patients who are submitted screening colonoscopy and they presented with cancerous lesion

时间窗: 1 month

次要结局

未报告次要终点

研究者

发起方
Evangelismos Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikos Viazis

Director Gastroenterology

Evangelismos Hospital

研究点 (1)

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