NCT05587452

Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence

Early Screening of Colorectal Cancer Based on Plasma Multi-omics Combining With Artificial Intelligence-a Multi-center, Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 950 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To evaluate the accuracy and effectiveness of a novel screening method based on plasma multi-omics combining with artificial intelligence in a large prospective cohort for the detection of colorectal cancer and advanced adenomas.

Detailed description

Minimally invasive detection of circulating tumor DNA (ctDNA) in peripheral blood of patients with colorectal malignancies via liquid biopsy has emerged as a promising biomarker. This is urgently needed, as conventional imaging and plasma protein-derived biomarkers lack sensitivity and specificity.The goal of this observational study is to evaluate the effectiveness and accuracy of a novel screening method based on plasma multi-omics combining with artificial intelligence in five hospitals around China for the detection of colorectal cancer and advanced adenomas.

Conditions

• Colorectal Adenoma
• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Colonoscopy	Colonoscopy is performed to identify whether the patient has colorectal adenoma or cancer
DIAGNOSTIC_TEST	Test of ctDNA methylation	A specified panel is used to detect the site of methylation of ctDNA in plasma
DIAGNOSTIC_TEST	Test of characteristics of ctDNA fragment	Low pass whole genome sequencing is used to detect the characteristics of ctDNA fragment

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2025-05-01
• First posted: 2022-10-20
• Last updated: 2022-10-24

Locations

5 sites across 1 country: China