This is a multicenter, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.
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 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, multicenter, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.
Study Type
OBSERVATIONAL
Enrollment
1,138
NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy
Fudan University Shanghai Cancer Center
Shanghai, China
Sensitivity
The sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer and adenoma
Time frame: 2 years
Specificity
The specificity of plasma ctDNA methylation haplotypes in healthy individuals
Time frame: 2 years
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