NCT04074538

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55,000

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2013Dec 2035

Study Start

First participant enrolled

January 1, 2013

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

22.9 years

First QC Date

August 26, 2019

Last Update Submit

August 28, 2019

Conditions

Keywords

colorectal cancercohort studyCRC screening

Outcome Measures

Primary Outcomes (4)

  • colorectal cancer incidence

    up to 15 years

  • Disease-free and overall survival

    up to 10 years

  • Recurrence/metastasis

    up to 5 years

  • Adenoma or advanced adenoma incidence

    up to 1 year

Secondary Outcomes (2)

  • Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE)

    up to 5 years

  • Second primary cancer incidence

    up to 15 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • A history of colorectal cancer or bowel resection
  • Non-Chinese speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Second Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, Zhejiang, 310999, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

West China Hospital

Chengdu, China

RECRUITING

Sun Yat-sen University

Guangzhou, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, China

RECRUITING

Related Publications (2)

  • 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). 2025 Nov 10. doi: 10.1097/CM9.0000000000003813. Online ahead of print.

  • Huang 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.

Biospecimen

Retention: SAMPLES WITH DNA

Formalin fixed and paraffin embedded (FFPE) and fresh frozen tissue (multiple sources/locations) from the tumor, blood, urine, feces

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Ke-feng Ding, PhD/MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 30, 2019

Study Start

January 1, 2013

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations