China Colorectal Cancer Screening 1 (C-Cost1)
China Colorectal Cancer Screening Trial 1 (C-Cost1): Colonoscopy Versus FIT Versus FIT Plus Blood Test in the Average Risk Population
This project will test whether one-time colonoscopy, annual FIT, or annual FIT plus a blood cfDNA methylation test best detects colorectal cancer and advanced adenomas in average-risk adults aged 45–74 in China.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60300 (estimated) |
| Ages | 45 Years to 74 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Locations | 7 sites (Guandong and 6 other locations) |
| Trial ID | NCT07090291 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 45–74 years old in generally good health, without prior colorectal cancer or recent colorectal examinations, who are at average risk and can provide informed consent.
Not a fit: People with a personal history of colorectal cancer or precancerous lesions, recent colonoscopy or stool/DNA/cfDNA testing, current cancer treatment, urgent GI symptoms, or severe comorbidities unlikely to tolerate screening are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could identify a more sensitive and feasible screening approach that detects cancers and precancerous lesions earlier, potentially reducing colorectal cancer deaths and treatment burden.
How similar studies have performed: Colonoscopy and FIT are established screening methods with demonstrated effectiveness, while blood-based cfDNA methylation tests are promising and have shown encouraging but still emerging results in early detection studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guandong and 6 other locations
- 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)
- Zhejiang Provincial Center for Disease Control and Prevention — Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Kefeng Ding, MD
- Email: dingkefeng@zju.edu.cn
- Phone: 86-571-87784827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.