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临床试验/NCT05170360
NCT05170360Unknown不适用

Evaluation of Some Risk Factors Associated With Colorectal Cancer and Their Correlation With KRAS and BRAF Genes Mutations

Assiut University0 个研究点目标入组 100 人开始时间: 2021年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
1. association between some risk factors and colorectal cancer

研究概览

简要总结

  1. Evaluation of some risk factors (e.g. smoking, heavy metal exposure, and organophosphorus exposure) on CRC.
  2. Estimation of KRAS and BRAF genes mutations associated with CRC.
  3. Association between different risk factors and gene mutations on different types of CRC.

详细描述

  • Colorectal cancer (CRC) ranks as the third most common cancer globally and second in terms of mortality (Bray et al., 2018). CRC is the 7th commonest cancer in Egypt, representing 3.47% of male cancers and 3% of female cancers (Metwally et al.,2018).
  • Studies have provided that rising CRC rates are associated with increased alcohol use, physical inactivity, high intake of fat, red and processed meat, and processed foods; and low intake of fiber (Zhou and Rifkin, 2021).
  • Smoking is an established risk factor for colorectal adenomas as well as CRC incidence and mortality, which suggests that it may affect the prognosis of CRC patients as well (Walter et al., 2014).
  • Heavy metals are natural components of the earth's crust, which, if released into the environment, can persist for many years (Wu et al., 2016). The most toxic elements are arsenic, cadmium, chromium, copper, mercury, and lead with the majority of them being classified as certainly or probably carcinogenic (Forte et al., 2020).
  • Pesticides that are applied to farms can remain in the environment for longer than intended (Sjerps et al., 2019). Pesticides increase the risk of cancer through a variety of mechanisms including genotoxicity, epigenetic effects, hormonal action, and immunotoxicity (Lyons and Watterson, 2010).
  • Of the key genes of CRC, KRAS mutations are the most widely known, as they are mainly localized in codons 12 and 13, which were among the first linked to the pathogenesis of colon cancer (Kudryavtseva et al., 2016). BRAF is an oncogene located on chromosome 7 for which gain of function mutations in multiple solid tumors, such as colon cancer (Frisone et al., 2020).

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients who are recently diagnosed with CRC based on clinical and pathological examinations.
  • •Control subjects will be CRC-free, based on the clinical history and physical examination.

排除标准

  • •1 - Patient refuses to be enrolled in the study.
  • •Subjects with cancer metastasized from other tissues to the colon. (colon is the site of metastasis)

结局指标

主要结局

1. association between some risk factors and colorectal cancer

时间窗: baseline

association between smoking( by measuring serum cotinine ng/ml) , heavy metal (by measuring lead and cadmium in the blood μg/dLwill be measured using Graphite Tube Atomizer) , organophosphorus exposure (By measuring serum pseudocholinesterase level U/ml by spectrophotometer) and colorectal cancer incidience

次要结局

  • 1. Estimation of KRAS and BRAF genes mutations associated with CRC. 3. Association between these risk factors and gene mutations on different types of CRC.(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Abdelsamee Mohammed Ali

Assistant lecturer in Forensic Medicine and Clinical Toxicology Department

Assiut University

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