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Individually Tailored Strategies for the Precision Prevention of Gastric Cancer and Colorectal Cancer in the Community

2020年6月18日 更新者:National Taiwan University Hospital

Gastric cancer is a global health threat. Helicobacter pylori is now recognized as the main risk factor that initiates this process; hence, H. pylori eradication has been considered the most effective method to ameliorate the burden of gastric cancer. Serum pepsinogen levels reveal the current atrophy of the stomach and predict gastric cancer risk. A risk prediction model with the combination of H. pylori infection and serum pepsinogen level could identify the highest-risk gastric cancer patients.

Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death in men and women, respectively. For CRC prevention, a two-stage approach using the fecal immunochemical test (FIT) is popular; besides, the FIT levels may serve as a guide for priority setting in prompting residents to undergo colonoscopy. Therefore, the effectiveness and utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer screening program for those with high FIT levels urgently need to evaluate.

研究概览

地位

邀请报名

条件

详细说明

Gastric cancer is a global health threat and contributes to more than 720,000 deaths per year. In the absence of early detection, gastric cancer is associated with a high fatality rate-the 5-year survival rate for patients with locally advanced disease is only about 40% despite aggressive treatment. Carcinogenesis in gastric cancer follows a multistage process (i.e., Correa's model) that develops from chronic active gastritis to atrophic gastritis, intestinal metaplasia, dysplasia, and finally to carcinoma. Helicobacter pylori is now recognized as the main risk factor that initiates this process. An estimated 89% of non-cardiac cancers can be prevented if H. pylori can be eradicated from the population of interest; hence, H. pylori eradication has been considered the most effective method to ameliorate the burden of gastric cancer. However, in the setting of mass screening, irreversible damage may already have occurred after patients have harbored H. pylori infection for decades before they undergo screening and treatment for H. pylori. This observation has been supported by a recent meta-analysis based on 8 randomized controlled trials and 16 cohort studies that investigated the magnitude of the benefit from eradication therapy; on average, only a 50% reduction of gastric cancer risk was shown. Altered levels of serum pepsinogens, which are mainly produced by the chief cells of the fundic glands of the stomach, reflect the atrophic status (ie, gland loss) of gastric mucosa. Serum pepsinogen levels not only reveal the past infection status or current atrophy of the stomach, respectively, but have also been shown to be predictive of gastric cancer risk. Therefore, to completely eliminate the burden of gastric cancer, physicians urgently need a risk prediction model with the combination of H. pylori infection and serum pepsinogen level to identify the highest-risk patients for endoscopic examination in the context of limited resources.

Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death in men and women, respectively, in the world. To reduce the burden of CRC, colonoscopy is the most effective method and can reduce the risk of new-onset CRCs by the removal of adenomatous polyps and can improve CRC survival by the detection of pre-symptomatic malignancies. In addition to primary screening colonoscopy, a two-stage approach using the fecal immunochemical test (FIT) is increasingly popular because of its ability to identify patients with the highest risk of CRC; in this manner, limited colonoscopist resources can be efficiently allocated. Although colonoscopy is associated with a statistically significant reduction in mortality rates for CRC through the detection of early-stage cancers, the FIT levels may serve as a guide for priority setting in prompting residents to undergo colonoscopy. Besides, the prevalence of any CRC and advanced-stage CRC is associated with delays in follow-up colonoscopies for patients with positive results from a FIT. Therefore, the effectiveness and utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer screening program for those with high FIT levels urgently need to evaluate.

研究类型

观察性的

注册 (预期的)

40000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾
        • National Taiwan University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

A community-based mass screening for gastric cancer and colorectal cancer is designed and targeted at community residents aged 50-75 years in Taiwan.

描述

Inclusion Criteria:

  1. Aged 50-75 years
  2. Confirmed non-gastric cancer/colorectal cancer healthy participant
  3. Mentally competent to be able to understand the consent form
  4. Able to communicate with study staff for individuals
  5. Agree to link the screening data to National Cancer Registry

Exclusion Criteria:

  1. Confirmed gastric cancer/colorectal cancer healthy participant
  2. Status post gastrectomy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Gastric cancer prevention
This prospective study consists of 40,000 participants; after randomization, each arm has 20,000 participants. Arm 1: participants receive H. pylori stool antigen test; Arm 2: participants receive the combination of H. pylori stool antigen test and serum pepsinogen test.
Colorectal cancer prevention
This prospective study consists of 40,000 participants; after randomization; each arm has 20,000 participants. Arm 1: participants with positive fecal immunochemical test (FIT) receive routine referral confirmatory diagnosis approach; Arm 2: participants with positive FIT receive routine referral confirmatory diagnosis approach and participants with high FIT results receive additional aggressive referral confirmatory diagnosis approach.

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
Gastric cancer prevention
大体时间:Up to 10 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.
To assess the combination of H. pylori stool antigen test and serum pepsinogen test as a joint predictor of gastric cancer risk
Up to 10 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.
Colorectal cancer prevention
大体时间:Up to 10 years, the colorectal cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.
To assess the effectiveness/utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer screening program
Up to 10 years, the colorectal cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:TSUNG-HSIEN CHIANG, MD, MSc、National Taiwan University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年4月14日

初级完成 (预期的)

2023年12月31日

研究完成 (预期的)

2029年12月31日

研究注册日期

首次提交

2019年1月2日

首先提交符合 QC 标准的

2019年1月2日

首次发布 (实际的)

2019年1月4日

研究记录更新

最后更新发布 (实际的)

2020年6月22日

上次提交的符合 QC 标准的更新

2020年6月18日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

No individual participant data could be shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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