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Clinical Trial Summary

This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.


Clinical Trial Description

Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03868215
Study type Observational
Source Fudan University
Contact Guoxiang Cai, M.D. Ph.D.
Phone +86 13611831623
Email gxcai@fudan.edu.cn
Status Recruiting
Phase
Start date May 1, 2018
Completion date August 31, 2020

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