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

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT04074538
• Lead Sponsor: Ding Ke-Feng

Brief Summary

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.

Study Timeline

• Study Start: 2013-01-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-28
• Last Update Submitted: 2019-08-28
• Study First Posted: 2019-08-30
• Last Update Posted: 2019-08-30
• Primary Completion: 2035-12
• Study Completion: 2035-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Sun Yat-sen University; 🇨🇳 Guangzhou, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China

Second Affiliated Hospital Zhejiang University College of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

West China Hospital; 🇨🇳 Chengdu, China