China Colorectal Cancer Screening Trial 1 (C-Cost1)

NCT07090291 | Recruiting

• 1 other identifier: C-Cost1
• Study Type: interventional
• Target: 60,300
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Colorectal Cancer; Advanced Adenoma

Keywords

FIT; FIT plus blood test; cfDNA methylation; Colorectal cancer; Advanced colorectal adenoma; Early screening; Average risk population

Outcome Measures

Primary Outcomes (1)

• Mortality rate of colorectal cancer

  Mortality rate of colorectal cancer

  10 years

Secondary Outcomes (7)

• Detection rate of advanced colorectal neoplasms

  4 years

• Population compliance rate

  4 years

• Proportion of colorectal cancer at different stages

  4 years

• Incidence rate of colorectal cancer

  10 years

• Quality of life (QOL)

  4 years

Study Arms (3)

Colonoscopy group

ACTIVE COMPARATOR

The internationally recommended screening protocol is adopted. The participants will only undergo a colonoscopy once at the first year. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. All the participants will then receive annual follow-ups for the next 3 years, followed by long-term follow-ups.

Diagnostic Test: Colonoscopy

FIT group

ACTIVE COMPARATOR

The internationally recommended screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests. Participants with positive FIT results are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT tests, have negative FIT tests, have positive FIT tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups.

Diagnostic Test: FIT

FIT plus blood test group

EXPERIMENTAL

A new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests and blood tests. Participants with positive FIT tests or positive blood tests are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT plus blood tests, have negative FIT plus blood tests, have positive FIT tests or positive blood tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups.

Diagnostic Test: FIT; Diagnostic Test: Blood test

Interventions

Colonoscopy DIAGNOSTIC_TEST

Colonoscopy is used to examine the inner lining of the colon and rectum. During the procedure, if suspicious growths (e.g., polyps) are detected, they will be biopsied and sent for pathological examination.

Colonoscopy group

FIT DIAGNOSTIC_TEST

FIT stands for Fecal Immunochemical Test, a non-invasive screening tool used primarily to detect hidden blood in the stool, which may indicate colorectal cancer or precancerous polyps. Positive cut-off level: 100 ng/mL.

FIT group; FIT plus blood test group

Blood test DIAGNOSTIC_TEST

Blood test based on cfDNA methylation will be performed.

FIT plus blood test group

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (7)

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

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy; Hematologic Tests

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Clinical Laboratory Techniques; Investigative Techniques

Central Study Contacts

Kefeng Ding, MD

CONTACT

86-571-87784827; dingkefeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 29, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2035
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)