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临床试验/NCT04512729
NCT04512729Unknown不适用

Detection Of Colonic Polyps In India: Diagnostic Colonoscopy

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2020年8月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,000
试验地点
1
主要终点
Colonic Adenoma

研究概览

简要总结

Colorectal carcinoma (CRC) is the third most common cancer in male and female worldwide. In India, it is the fourth most common cause of cancer in males and third most common cancer in female. Age, smoking, colonic adenomatous polyp, family history are traditional risk factor for CRC. The vast majority of CRC results from malignant transformation from adenoma, which is called as adenoma carcinoma sequence. These adenomatous polyps grows slowly over many years and malignant transformation eventually occurs over 10 years. So, the early detection and removal of polyp at early stage should benefit in preventing CRC.

详细描述

The third most common cancer in both male and female is colorectal carcinoma (CRC) worldwide. In India, it is the fourth most common cause of cancer in males and third most common cancer in females. The age - standardized rates of CRC in India have been estimated to be 4.2 and 3.2/100000 for males and females, respectively. Age, smoking and colonic adenoma along with family history is considered as traditional risk factors for CRC. The US National Polyp study demonstrated that colonoscopy and polypectomy could prevent 76% to 90% of colorectal cancers. The vast majority of CRC result from malignant transformation from adenomas. This is called adenoma - carcinoma sequence, these adenomatous polyps grows slowly over many years and malignant transformation eventually occurs. The time span for this transformation is on an average 10 years. So, the detection and removal of polyp at early stage on adenoma - carcinoma sequence should benefit in preventing CRC.

The prevalence of adenoma, utilization of colonoscopy for its detection and subsequent reduction in CRC has been well studied and established in western population. This has led to formulation of national screening colonoscopy programs elsewhere. However, data from Indian subcontinent is scanty. In current study, at a large tertiary care center, we aimed to study prevalence of colonic polyps and adenoma who are undergoing diagnostic colonoscopy using high definition colonoscopy and characterizing with Narrow Band Imaging and to find associated demographic, social, personal and family related risk factors in patients with adenomas.

Methodology:

This will be a prospective, single center, observational study. All subjects referred for diagnostic colonoscopy will be prospectively enrolled.

Enrollment:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Referral for diagnostic colonoscopy
  • Ability to provide informed consent

排除标准

  • Inability or not willing to give informed consent

结局指标

主要结局

Colonic Adenoma

时间窗: 1 year

To evaluate prevalence of colonic polyps and adenomas in Indian Population

次要结局

  • Risk factors for Colonic adenoma(1 year)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

Principal Investigator

Asian Institute of Gastroenterology, India

研究点 (1)

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