Clinical trial NCT04074538: the National Colorectal Cancer Cohort (NCRCC) Study: National Colorectal Cancer Research Consortium
Official title: The National Colorectal Cancer Cohort Study-Precision Medical Research in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: colorectal cancer
cohort study
CRC screening
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: West China Hospital
name: Sun Yat-sen University
name: Shanghai Zhongshan Hospital
name: Peking University People's Hospital
name: Peking University Cancer Hospital & Institute
name: Fujian Cancer Hospital
name: Hubei Cancer Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Shanxi Province Cancer Hospital
name: Changhai Hospital
name: Zhejiang Cancer Hospital
name: Third Affiliated Hospital of Third Military Medical University
name: Air Force Military Medical University, China
name: Sixth Affiliated Hospital, Sun Yat-sen University
First posted: 2019-08-30
Enrollment: 55000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: colorectal cancer incidence
timeFrame: up to 15 years
measure: Disease-free and overall survival
timeFrame: up to 10 years
measure: Recurrence/metastasis
timeFrame: up to 5 years
measure: Adenoma or advanced adenoma incidence
timeFrame: up to 1 year
Secondary outcomes:
measure: Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE)
timeFrame: up to 5 years
measure: Second primary cancer incidence
timeFrame: up to 15 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Chengdu
country: China
facility: West China Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
References: