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

August 28, 2019 updated by: Ding Ke-Feng

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

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

Study Overview

Status

Recruiting

Conditions

Colorectal Cancer

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).

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.

Study Type

Observational

Enrollment (Anticipated)

55000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Beijing, China
    - Recruiting
    - Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    - Contact:
      
      Zheng Zhaoxu
  - Chengdu, China
    - Recruiting
    - West China Hospital
    - Contact:
      
      Wang Ziqiang
  - Guangzhou, China
    - Recruiting
    - Sun Yat-sen University
    - Contact:
      
      Pan Zhizhong
  - Shanghai, China
    - Recruiting
    - Shanghai Zhongshan Hospital
- Zhejiang
  - Hangzhou, Zhejiang, China, 310999
    - Recruiting
    - Second Affiliated Hospital Zhejiang University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NCRCC study consists of two subcohorts (CRC Screening Cohort and Colorectal Cancer Patient Cohort).

CRC Screening Cohort is a population-bsaed study. All aged 40-74 years old individuals without prior colorectal cancer or bowel resection are recruited.

All consecutive patients who were newly diagnosed with primary invasive or metastatic colorectal cancer are eligible for Colorectal Cancer Patient Cohort.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
colorectal cancer incidence Time Frame: up to 15 years	up to 15 years
Disease-free and overall survival Time Frame: up to 10 years	up to 10 years
Recurrence/metastasis Time Frame: up to 5 years	up to 5 years
Adenoma or advanced adenoma incidence Time Frame: up to 1 year	up to 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ding Ke-Feng

Collaborators

The First Affiliated Hospital with Nanjing Medical University

Zhejiang Cancer Hospital

Changhai Hospital

Shanxi Province Cancer Hospital

Peking University People's Hospital

Sun Yat-sen University

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Shanghai Zhongshan Hospital

Fujian Cancer Hospital

West China Hospital

Hubei Cancer Hospital

Peking University Cancer Hospital & Institute

Sixth Affiliated Hospital, Sun Yat-sen University

Air Force Military Medical University, China

Third Affiliated Hospital of Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2035

Study Completion (ANTICIPATED)

December 1, 2035

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (ACTUAL)

August 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)