China Colorectal Cancer Screening 1 (C-Cost1)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a large cluster-randomized trial in China enrolling at least 60,300 average-risk adults aged 45–74 and randomizing clusters to three screening strategies. One arm receives a one-time colonoscopy at baseline, the second receives annual fecal immunochemical tests (FIT) for four years with colonoscopy if FIT-positive, and the third combines annual FIT with a blood-based cfDNA methylation test. Fecal, blood, and tissue samples will be collected, suspicious lesions resected and pathologically examined, and all participants will be followed annually during a 4-year screening phase and then long-term. The trial aims to compare detection rates of colorectal cancer and advanced adenomas and inform screening approaches for the average-risk population in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 45-74 years old;
2. In good general condition, with normal mental state and voluntarily signing the informed consent form;

Exclusion Criteria:

1. Personal history of colorectal cancer or precancerous lesions;
2. History of previous colonrectal resection surgery;
3. Diagnosed with cancer before enrollment or currently receiving any cancer-related treatment;
4. Having received colonoscopy, flexible sigmoidoscopy, CT colonography and other examinations within the past 5 years;
5. Having received FIT or FIT-sDNA or cfDNA test within the past 1 year;
6. Symptomatic lower gastrointestinal diseases or symptoms suggesting the need for diagnostic colonoscopy for confirmation;
7. Accompanied by severe diseases that are not suitable for colorectal cancer screening;

Where it's running

• Sun Yat-sen University Cancer Center
  Guandong, China Recruiting
• Maoming People's Hospital
  Guangdong, China Recruiting
• The Fourth Hospital of Hebei Medical University
  Hebei, China Recruiting
• Nanjing Medical University
  Nanjing, China Recruiting
• Shanghai Municipal Center For Disease Control & Prevention
  Shanghai, China Recruiting
• Sichuan Cancer Hospital & Institute, Sichuan Cancer Center
  Sichuan, China Recruiting

Study contacts

• Study coordinator: Kefeng Ding, MD
• Email: dingkefeng@zju.edu.cn
• Phone: 86-571-87784827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.