Multi-omics Study for Early Detection of Colorectal Cancer (MOED-CRC)

Colorectal Cancer Clinical Trial

Official title: Multi-omics Study for Early Detection of Colorectal Cancer Based on Liquid Biopsy Technology

Status Recruiting

Clinical Trial Summary

The primary objective of the study is to screen multi-omics markers in blood samples and construct a prediction model for CRC based on liquid biopsy, and we will further optimize the prediction model by validating its clinical performance externally.

Clinical Trial Description

This multicenter research intends to enroll 3,600 participants according to predefined inclusion and exclusion criteria. The study will be divided into two groups: the "cancer arm" and the "control arm", with the "control arm" further subdivided into the "general-risk arm" and the "high-risk arm". All participants enrolled in this study will be required to provide a 10 ml whole blood sample.

This study consists of two sections. The first section involves constructing an diagnostic prediction model for early CRC detection, and the second section focuses on validating and optimizing this prediction model.

In the first section, a prediction model for the early detection of CRC will be developed with a cohort of 1,700 participants. This cohort comprises 900 individuals in the cancer arm, including 800 CRC patients and 100 with advanced adenoma (AA), along with 800 individuals in the control rm. All participants will be required to provide a 10 ml blood sample. Cell-free DNA (cfDNA) and microRNA (miRNA) will be sequenced and analyzed with the next-generation sequencing (NGS) platform,. And cancer specific markers will be identified to construct an early detection liquid biopsy prediction model by leveraging machine learning techniques and incorporating clinical pathological diagnostic information.

In the second section, a total of 1,900 participants were include, with 1,100 in the "cancer arm" (800 CRC and 300 AA patients) and 800 in the "control arm", the prediction model established in the first section will be validated in an external cohort, and algorithm optimization will be performed. ;

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Advanced Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT06220617
• Study type: Observational
• Source: Zhejiang University
• Contact: Kefeng Ding, MD
• Phone: 86-571-87784827
• Email: dingkefeng@zju.edu.cn
• Status: Recruiting
• Start date: January 11, 2024
• Completion date: June 30, 2027