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Recruiting NCT04074538

the National Colorectal Cancer Cohort (NCRCC) Study: National Colorectal Cancer Research Consortium

— Observational Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Primary outcome measures

  • colorectal cancer incidence [Time frame: up to 15 years]
  • Disease-free and overall survival [Time frame: up to 10 years]
  • Recurrence/metastasis [Time frame: up to 5 years]
  • Adenoma or advanced adenoma incidence [Time frame: up to 1 year]
Secondary outcome measures (2)
  • Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE) [Time frame: up to 5 years]
  • Second primary cancer incidence [Time frame: up to 15 years]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 5 centers
  • Second Affiliated Hospital Zhejiang University College of Medicine — Hangzhou
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing
  • West China Hospital — Chengdu
  • Sun Yat-sen University — Guangzhou
  • Shanghai Zhongshan Hospital — Shanghai

Publications

  • Huang F, Xiao T, Li K, Wei R, Mei S, Zhao W, Wei F, He M, Zheng Z, Liu Q. Benefit of oxaliplatin-based chemotherapy or capecitabine monotherapy in older patients with stage III and high-risk stage II colon cancer: Data from the National Colorectal Cancer Cohort study in China. Chin Med J (Engl). 2026 Jul 5;139(13):1993-2001. doi: 10.1097/CM9.0000000000003813. Epub 2025 Nov 10. PMID 41213862
  • Huang F, Jiang S, Wei R, Xiao T, Wei F, Zheng Z, Liu Q. Association of resection margin distance with anastomotic recurrence in stage I-III colon cancer: data from the National Colorectal Cancer Cohort (NCRCC) study in China. Int J Colorectal Dis. 2024 Jul 12;39(1):105. doi: 10.1007/s00384-024-04684-x. PMID 38995409

Identifiers

NCT: NCT04074538 · CRCCZ-ncrcc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗