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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074538
• Other study ID #: CRCCZ-ncrcc
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 2035

Study information

• Verified date: August 2019
• Source: Zhejiang University
• Contact: Ke-feng Ding, PhD/MD
• Phone: 86-571-87784827
• Email: dingkefeng[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55000
• Est. completion date: December 2035
• Est. primary completion date: December 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?-? (CRCPC)

Exclusion Criteria:

• A history of colorectal cancer or bowel resection

• Non-Chinese speaking

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	West China Hospital	Chengdu
China	Sun Yat-sen University	Guangzhou
China	Second Affiliated Hospital Zhejiang University College of Medicine	Hangzhou	Zhejiang
China	Shanghai Zhongshan Hospital	Shanghai

Sponsors (16)

Lead Sponsor

Collaborator

Ding Ke-Feng

Beijing Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Changhai Hospital, Fourth Military Medical University, Fujian Cancer Hospital, Hubei Cancer Hospital, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	colorectal cancer incidence		up to 15 years
Primary	Disease-free and overall survival		up to 10 years
Primary	Recurrence/metastasis		up to 5 years
Primary	Adenoma or advanced adenoma incidence		up to 1 year
Secondary	Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE)		up to 5 years
Secondary	Second primary cancer incidence		up to 15 years