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NCT Number: NCT04074538

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

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

Recruiting

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, Zhejiang, China

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About this study

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).

  • To assess risk factors for colorectal cancer and evaluate risk prediction model of colorectal cancer to identify the high-risk population.
  • 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).
  • To estimate associations of epidemiological determinants (e.g. medication and supplement use, diet, lifestyle pattern) with clinical outcomes and survivorship endpoints among CRC patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. colorectal cancer incidence

    Time frame: up to 15 years

  2. Disease-free and overall survival

    Time frame: up to 10 years

  3. Recurrence/metastasis

    Time frame: up to 5 years

  4. Adenoma or advanced adenoma incidence

    Time frame: up to 1 year

Secondary outcomes

  1. Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE)

    Time frame: up to 5 years

  2. Second primary cancer incidence

    Time frame: up to 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ke-feng Ding, PhD/MD

CONTACT

[email protected]

86-571-87784827

Sponsors and collaborators

Lead sponsor

Ding Ke-Feng

Other

Collaborators

  • Air Force Military Medical University, China
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Changhai Hospital
  • Fujian Cancer Hospital
  • Hubei Cancer Hospital
  • Peking University Cancer Hospital & Institute
  • Peking University People's Hospital
  • Shanghai Zhongshan Hospital
  • Shanxi Province Cancer Hospital
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • Sun Yat-sen University
  • The First Affiliated Hospital with Nanjing Medical University
  • Third Affiliated Hospital of Third Military Medical University
  • West China Hospital
  • Zhejiang Cancer Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2035
Study completion
2035
First posted
Aug 30, 2019
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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