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临床试验/NCT04074538
NCT04074538招募中不适用

The National Colorectal Cancer Cohort Study-Precision Medical Research in Colorectal Cancer

Ding Ke-Feng5 个研究点 分布在 1 个国家目标入组 55,000 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
55,000
试验地点
5
主要终点
Recurrence/metastasis

研究概览

简要总结

NCRCC study is a national prospective cohort study including colorectal cancer screening population and stage Ⅰ-Ⅳ colorectal cancer patients.

详细描述

NCRCC study is a large-scale multicenter study which includes 16 hospitals and research centers, establishing a national cohort which consists of two subcohorts (CRC Screening Cohort and Colorectal Cancer Patient Cohort).

  1. To assess risk factors for colorectal cancer and evaluate risk prediction model of colorectal cancer to identify the high-risk population.
  2. To discover, test and validate new biological markers (e.g. genetic, epigenetic, transcriptomic, metabolomics, proteomic and metagenomics biomarkers) for early diagnosis, prediction of clinical outcomes (e.g. therapeutic response, toxicity, surgical complications) and survivorship endpoints (e.g. recurrence, survival, quality of life, second primary cancer).
  3. To estimate associations of epidemiological determinants (e.g. medication and supplement use, diet, lifestyle pattern) with clinical outcomes and survivorship endpoints among CRC patients.

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

  • Men and women
  • Mentally/physically able to consent and participate
  • Subjects aged ≥18 years old (Colorectal Cancer Patient Cohort, CRCPC), age 40-74 years (CRC Screening Cohort, CRCSC)
  • Newly-diagnosed colon and rectal cancer for stages Ⅰ-Ⅳ (CRCPC)

排除标准

  • A history of colorectal cancer or bowel resection
  • Non-Chinese speaking

结局指标

主要结局

Recurrence/metastasis

时间窗: up to 5 years

colorectal cancer incidence

时间窗: up to 15 years

Disease-free and overall survival

时间窗: up to 10 years

Adenoma or advanced adenoma incidence

时间窗: up to 1 year

次要结局

  • Second primary cancer incidence(up to 15 years)
  • Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE)(up to 5 years)

研究者

发起方
Ding Ke-Feng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ding Ke-Feng

Professor

Zhejiang University

研究点 (5)

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