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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074538
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
West China Hospital
Sun Yat-sen University
Shanghai Zhongshan Hospital
Peking University People's Hospital
Beijing Cancer Hospital
Fujian Cancer Hospital
Hubei Cancer Hospital
The First Affiliated Hospital with Nanjing Medical University
Shanxi Province Cancer Hospital
Changhai Hospital
Zhejiang Cancer Hospital
Third Affiliated Hospital of Third Military Medical University
Fourth Military Medical University
Sixth Affiliated Hospital, Sun Yat-sen University
Information provided by (Responsible Party):
Ding Ke-Feng, Zhejiang University

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

Condition or disease
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).

  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.

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Study Type : Observational
Estimated Enrollment : 55000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The National Colorectal Cancer Cohort Study-Precision Medical Research in Colorectal Cancer
Actual Study Start Date : January 1, 2013
Estimated Primary Completion Date : December 2035
Estimated Study Completion Date : December 2035

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Formalin fixed and paraffin embedded (FFPE) and fresh frozen tissue (multiple sources/locations) from the tumor, blood, urine, feces


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074538


Contacts
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Contact: Ke-feng Ding, PhD/MD 86-571-87784827 dingkefeng@zju.edu.cn

Locations
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China, Zhejiang
Second Affiliated Hospital Zhejiang University College of Medicine Recruiting
Hangzhou, Zhejiang, China, 310999
Contact: Ke-Feng Ding, PhD/MD    86-571-87784827    dingkefeng@zju.edu.cn   
Principal Investigator: Ke-Feng Ding, PhD/MD         
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Zheng Zhaoxu         
West China Hospital Recruiting
Chengdu, China
Contact: Wang Ziqiang         
Sun Yat-sen University Recruiting
Guangzhou, China
Contact: Pan Zhizhong         
Shanghai Zhongshan Hospital Recruiting
Shanghai, China
Contact: Wei Ye         
Sponsors and Collaborators
Ding Ke-Feng
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
West China Hospital
Sun Yat-sen University
Shanghai Zhongshan Hospital
Peking University People's Hospital
Beijing Cancer Hospital
Fujian Cancer Hospital
Hubei Cancer Hospital
The First Affiliated Hospital with Nanjing Medical University
Shanxi Province Cancer Hospital
Changhai Hospital
Zhejiang Cancer Hospital
Third Affiliated Hospital of Third Military Medical University
Fourth Military Medical University
Sixth Affiliated Hospital, Sun Yat-sen University
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Responsible Party: Ding Ke-Feng, Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT04074538    
Other Study ID Numbers: CRCCZ-ncrcc
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ding Ke-Feng, Zhejiang University:
colorectal cancer
cohort study
CRC screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases