Spots Global Cancer Trial Database for Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis

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Trial Identification

Brief Title: Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis

Official Title: Use of Plasma ctDNA Methylation Haplotypes in Detecting Local Residual or Lymph Node Metastasis: a Prospective, Clinical Study

Study ID: NCT03868215

Conditions

Colorectal Cancer

Lymph Node Metastases

Interventions

Next-generation sequencing (NGS)

Study Description

Brief 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.

Detailed 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.