Colorectal CancerNCT04074538
the National Colorectal Cancer Cohort (NCRCC) Study: National Colorectal Cancer Research Consortium
An observational study of Colorectal Cancer, run by Ding Ke-Feng at 5 sites in China.
Trial summary
NCRCC study is a national prospective cohort study including colorectal cancer screening population and stage Ⅰ-Ⅳ colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 55,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2013to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- A history of colorectal cancer or bowel resection
- Non-Chinese speaking
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Zheng Zhaoxu
- Recruiting
West China Hospital
Chengdu
Wang Ziqiang
- Recruiting
Sun Yat-sen University
Guangzhou
Pan Zhizhong
- Recruiting
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310999
Ke-Feng Ding, PhD/MD, 86-571-87784827, dingkefeng@zju.edu.cn
Ke-Feng Ding, PhD/MD
- Recruiting
Shanghai Zhongshan Hospital
Shanghai
Wei Ye
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, cohort study, CRC screening
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
colorectal cancer incidence
Measured: up to 15 years
Disease-free and overall survival
Measured: up to 10 years
Recurrence/metastasis
Measured: up to 5 years
Adenoma or advanced adenoma incidence
Measured: up to 1 year
Secondary outcomes (2)
Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE)
Measured: up to 5 years
Second primary cancer incidence
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Jan 2013
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ding Ke-Feng
- Sponsor type
- University, hospital or other
- 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, Peking University Cancer Hospital & Institute, 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, Air Force Military Medical University, China, Sixth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Ding Ke-Feng, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074538
- Sponsor's protocol ID
- CRCCZ-ncrcc
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang F, Xiao T, Li K, Wei R, Mei S, Zhao W, Wei F, He M, Zheng Z, Liu Q. Benefit of oxaliplatin-based chemotherapy or capecitabine monotherapy in older patients with stage III and high-risk stage II colon cancer: Data from the National Colorectal Cancer Cohort study in China. Chin Med J (Engl). 2026 Jul 5;139(13):1993-2001. doi: 10.1097/CM9.0000000000003813. Epub 2025 Nov 10.
PubMed 41213862Huang F, Jiang S, Wei R, Xiao T, Wei F, Zheng Z, Liu Q. Association of resection margin distance with anastomotic recurrence in stage I-III colon cancer: data from the National Colorectal Cancer Cohort (NCRCC) study in China. Int J Colorectal Dis. 2024 Jul 12;39(1):105. doi: 10.1007/s00384-024-04684-x.
PubMed 38995409
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Colorectal Cancer Cohort Study-Precision Medical Research in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04074538
- Acronym / sponsor ID
- CRCCZ-ncrcc
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, cohort study, CRC screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55,000 participants (estimated)
- Lead sponsor
- Ding Ke-FengUniversity, hospital or other
- 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, Peking University Cancer Hospital & Institute, 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, Air Force Military Medical University, China, Sixth Affiliated Hospital, Sun Yat-sen University
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- A history of colorectal cancer or bowel resection
- Non-Chinese speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
colorectal cancer incidence
Time frame: up to 15 years
Disease-free and overall survival
Time frame: up to 10 years
Recurrence/metastasis
Time frame: up to 5 years
Adenoma or advanced adenoma incidence
Time frame: up to 1 year
2 secondary outcomes
Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE)
Time frame: up to 5 years
Second primary cancer incidence
Time frame: up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Derived from this study: PubMed 41213862Huang F, Xiao T, Li K, Wei R, Mei S, Zhao W, Wei F, He M, Zheng Z, Liu Q. Benefit of oxaliplatin-based chemotherapy or capecitabine monotherapy in older patients with stage III and high-risk stage II colon cancer: Data from the National Colorectal Cancer Cohort study in China. Chin Med J (Engl). 2026 Jul 5;139(13):1993-2001. doi: 10.1097/CM9.0000000000003813. Epub 2025 Nov 10.
- Derived from this study: PubMed 38995409Huang F, Jiang S, Wei R, Xiao T, Wei F, Zheng Z, Liu Q. Association of resection margin distance with anastomotic recurrence in stage I-III colon cancer: data from the National Colorectal Cancer Cohort (NCRCC) study in China. Int J Colorectal Dis. 2024 Jul 12;39(1):105. doi: 10.1007/s00384-024-04684-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Ding Ke-Feng at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke-feng Ding, PhD/MD (86-571-87784827, dingkefeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colorectal cancer incidence (time frame: up to 15 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074538, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.