China Colorectal Cancer Screening Trial 1 (C-Cost1)

Recruiting now · Not applicable

Conditions studied: Colorectal Cancer, Advanced Adenoma

In brief

Colorectal cancer (CRC) is one of the most common malignancies in China. Currently, its incidence rate is increasing at a rate of 4% per year, exceeding the global annual average growth rate. Screening and early diagnosis of colorectal cancer and precancerous lesions are key measures to reduce the disease burden of colorectal cancer in China. In previous clinical studies, colorectal cancer screening in high risk population received extensive attention. However, it cannot be ignored that the majority of sporadic colorectal cancers occur in the average risk population. Therefore, there is an urgent need to develop new approach for colorectal cancer screening in the average risk population in China. Fecal Immunochemical Testing (FIT) initial screening followed by diagnostic colonoscopy is widely recommended by colorectal cancer screening guidelines worldwide. The current colorectal cancer screening approach faces challenges including limited sensitivity of initial screening technologies and insufficient population coverage in organized screening programs in China. As initial screening technologies, non-invasive blood tests which detects cfDNA methylation have been reported to have higher accuracy than FIT in detecting colorectal cancer. However, There is a lack of randomized controlled trials (RCTs) comparing the effectiveness of colonoscopy, FIT and FIT plus blood test for colorectal cancer screening. In China Colorectal Cancer Screening Trial 1 (C-Cost1), we propose to perform a multicenter, cluster randomized, parallel group trial directly comparing colonoscopy with FIT and with FIT plus blood test in the average risk population in China. The main research hypotheses are: (1) The screening protocol of FIT group (Group B) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years; (2) The screening protocol of FIT plus blood test group (Group C) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years. Both of the two hypotheses should be met.

Key facts

Study ID: NCT07090291
Run by: Zhejiang University
People needed: 60300
Starts: 2025-08-08
Expected to finish: 2035-07-01
Last updated by the study team: 2026-04-14

Who can join

Age: 45 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Sun Yat-sen University Cancer Center — Guandong, China (enrolling)
Maoming People's Hospital — Guangdong, China (enrolling)
The Fourth Hospital of Hebei Medical University — Hebei, China (enrolling)
Nanjing Medical University — Nanjing, China (enrolling)
Shanghai Municipal Center For Disease Control & Prevention — Shanghai, China (enrolling)
Sichuan Cancer Hospital & Institute, Sichuan Cancer Center — Sichuan, China (enrolling)
Zhejiang Provincial Center for Disease Control and Prevention — Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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