China Colorectal Cancer Screening Trial 2 (C-Cost2)

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. Stool DNA tests detect DNA biomarkers of tumor cells in the stool and have higher sensitivity in detecting advanced colorectal neoplasms. USPSTF has recommended FIT-sDNA as initial screening tests in the average risk population. Colorectal Cancer Early Screening in China (Clear-C) trial has reported FIT-sDNA had higher sensitivity than FIT in detecting advanced colorectal neoplasms among high risk population, yet there is a lack of randomized controlled trials (RCTs) directly comparing the effectiveness of FIT and FIT-sDNA for colorectal cancer screening in the average risk population in China.

In China Colorectal Cancer Screening Trial 2 (C-Cost2), we propose to perform a multicenter, individual-level randomized, parallel group trial directly comparing FIT and FIT-sDNA in the average risk population in China. The main research hypothesis is that the screening protocol of FIT-sDNA group (Group B) has a superior detection rate of advanced colorectal neoplasms compared to the FIT group (Group A).

Conditions

• Colorectal Cancer
• Advanced Adenoma

Interventions

DIAGNOSTIC_TEST

FIT

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.

DIAGNOSTIC_TEST

FIT-sDNA

FIT-sDNA test combines Fecal Immunochemical Test (FIT) and stool DNA (sDNA) analysis. It detects hemoglobin in stool through FIT to identify occult blood in the gastrointestinal tract and simultaneously analyzes specific DNA mutations or epigenetic alterations (such as methylation changes) in stool DNA to assess the risk of colorectal neoplasms.

Sponsors & Collaborators

• Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-31

Primary Completion

2028-11-30

Completion

2028-11-30